Clinical trial NCT00501059: A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate Risk of CVD
Keywords: Primary prevention of coronary heart disease
Stroke and cardiovascular death
Aspirin
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-07-13
Enrollment: 12546
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.

Detailed description: Summary of substantial Protocol amendments

Amendment #2 from 09-APR-2008:

* Systolic blood pressure (SBP) limit of 170 mmHg has been added to the exclusion criteria
* Exclusion of patients currently taking anticoagulant medication
* A longer interval between the daily dose of study drug and ibuprofen
* Revised wording in moderate risk definitions for coronary heart disease (CHD) and cerebrovascular disease (CVD): "To evaluate the clinical effects of a 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events (approximately 10 to 20% 10-year CHD risk; approximately 20 to 30% 10-year risk of CVD). This corresponds to a patient population mean 10-year CVD risk of approximately 30%."

Amendment #3 from 02-JAN-2009

• Increase in the number of allowed risk factors for males, age is no longer a risk factor

Amendment #4 from 02-OCT-2013

* The primary endpoint is changed to include confirmed UA and TIA.
* The estimated event rate is changed to 1.5% per year due to new information.
* Effect size (risk reduction) changed from 14.9% to 17 to 18%.
* Achieving 60,000 person-years instead of 1488 primary endpoint events
* Additional treatment and follow-up for a maximum of another 12 months.
* Change to reduced adverse event and concomitant therapy reporting

Eligibility criteria: Inclusion Criteria:

* Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:

  * Elevated cholesterol (Tchol\>200 mg/dL or LDL\>130 mg/dL; as measured at screening) irrespective of current treatment
  * Current smoking: defined as any cigarette smoking in the past 12 months
  * Low HDL cholesterol (HDL\<40 mg/dL; as measured at screening)
  * Elevated blood pressure (SBP\>140 mmHg; as measured at screening)
  * Currently on any medication to treat high blood pressure
  * Positive family history of early CHD (a first-degree relative \[father, mother, brother, sister, son, daughter\] suffered a heart attack \[myocardial infarction\] before the age of 60 years)
* Females aged 60 and above with 3 or more risk factors. Female Risk Factors:

  * Elevated cholesterol (Tchol\>240 mg/dL or LDL\>160 mg/dL; as measured at screening) irrespective of current treatment
  * Current smoking: defined as any cigarette smoking in the past 12 months
  * Low HDL cholesterol (HDL\<40 mg/dL; as measured at screening)
  * Elevated blood pressure (SBP\>140 mmHg; as measured at screening)
  * Currently on any medication to treat high blood pressure
  * Positive family history of early CHD (a first-degree relative \[father, mother, brother, sister, son, daughter\] suffered a heart attack \[myocardial infarction\] before the age of 60 years)
* An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial

Exclusion Criteria:

* History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention
* Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score
* Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
* Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders
* Active diagnosed and documented reflux esophagitis
* Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
* Lactating women or women of childbearing potential
* Severe liver disease or damage based on the clinical judgment of the investigator
* Severe renal disease or damage based on the clinical judgement of the investigator
* A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
* A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS
* Chronic, frequent (\> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole
* Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit
* Current use of an anticoagulant medication
* Sitting systolic blood pressure greater than 170 mmHg

Primary outcomes:
measure: Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)
timeFrame: Until follow-up (approximate 6 years)
Secondary outcomes:
measure: Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)
timeFrame: Until follow-up (approximate 6 years)
measure: Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
timeFrame: Until follow-up (approximately 6 years)
measure: Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
timeFrame: Until follow-up (approximately 6 years)
measure: Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer
timeFrame: Until follow-up (approximately 6 years)
measure: Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately
timeFrame: Until follow-up (approximately 6 years)
Other outcomes:
measure: Number of Subjects With Adjudicated GI Bleeding by Severity
timeFrame: Until follow-up (approximate 6 years)
measure: Incidence of Composite Outcomes and Non-fatal MI
timeFrame: Until follow-up (approximate 6 years)
measure: Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
timeFrame: Until follow-up (approximate 6 years)
Locations:
city: Birmingham
country: United States
state: Alabama
city: Graysville
country: United States
state: Alabama
city: Pell City
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Fremont
country: United States
state: California
city: Huntington Park
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Rancho Cucamonga
country: United States
state: California
city: Rolling Hills Estates
country: United States
state: California
city: Santa Ana
country: United States
facility: Helping Hands Clinical Trials
state: California
city: Newark
country: United States
state: Delaware
city: Boynton Beach
country: United States
facility: Medical Research Trust
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Hollywood
country: United States
facility: Medical Research Centers of South Florida, Inc.
state: Florida
city: Hollywood
country: United States
facility: Office of Dr.Larry Levinson, DO
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Marianna
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Quincy
country: United States
facility: Tallahassee Memorial Family
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city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Lockport
country: United States
state: Illinois
city: Vernon Hills
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Fort Wayne
country: United States
state: Indiana
city: Lebanon
country: United States
state: Kentucky
city: Prince Frederick
country: United States
state: Maryland
city: Bridgman
country: United States
state: Michigan
city: Cadillac
country: United States
state: Michigan
city: Interlochen
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Port Gibson
country: United States
state: Mississippi
city: Florissant
country: United States
state: Missouri
city: Broken Bow
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Omaha
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state: Nebraska
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city: Jersey City
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state: New Jersey
city: Lawrenceville
country: United States
state: New Jersey
city: Linden
country: United States
state: New Jersey
city: Perth Amboy
country: United States
facility: PharmaTrials, Inc.
state: New Jersey
city: Stratford
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city: Burlington
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state: North Carolina
city: Columbus
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state: North Carolina
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state: Texas
city: Sugar Land
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state: Texas
city: Honaker
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state: Virginia
city: Richlands
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facility: Merit Medical Group, Inc.
state: Virginia
city: Benningen
country: Germany
state: Baden-Württemberg
city: Deggingen
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state: Baden-Württemberg
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city: Hamburg
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city: Rehburg-Loccum
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city: Riede
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city: Thedinghausen
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city: Bishopstown
country: Ireland
state: Cork
city: Kilmallock
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state: Limerick
city: Rathkeale
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city: Tallow
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country: United Kingdom
state: Cornwall
city: Penzance
country: United Kingdom
state: Cornwall
city: Saltash
country: United Kingdom
state: Cornwall
city: St Austell
country: United Kingdom
state: Cornwall
city: Chesterfield
country: United Kingdom
state: Derbyshire
city: Dronfield
country: United Kingdom
state: Derbyshire
city: Plymouth
country: United Kingdom
state: Devon
city: Carryduff
country: United Kingdom
state: Down
city: Annan
country: United Kingdom
state: Dumfries And Galloway
city: Bishop Auckland
country: United Kingdom
state: Durham
city: Darlington
country: United Kingdom
state: Durham
city: Darlington
country: United Kingdom
state: Durham
city: Darlington
country: United Kingdom
state: Durham
city: Leigh-on-Sea
country: United Kingdom
state: Essex
city: Tiptree
country: United Kingdom
state: Essex
city: High Valleyfield
country: United Kingdom
state: Fife
city: Glasgow
country: United Kingdom
state: Glasgow City
city: Bangor
country: United Kingdom
state: Gwynedd
city: Hitchin
country: United Kingdom
state: Hertfordshire
city: Letchworth
country: United Kingdom
state: Hertfordshire
city: Letchworth
country: United Kingdom
state: Hertfordshire
city: Canterbury
country: United Kingdom
state: Kent
city: Chestfield
country: United Kingdom
state: Kent
city: Whitstable
country: United Kingdom
state: Kent
city: Carstairs
country: United Kingdom
state: Lanarkshire
city: Coatbridge
country: United Kingdom
state: Lanarkshire
city: Forth
country: United Kingdom
state: Lanarkshire
city: Blackpool
country: United Kingdom
state: Lancashire
city: Blackpool
country: United Kingdom
state: Lancashire
city: Bolton
country: United Kingdom
state: Lancashire
city: Bolton
country: United Kingdom
state: Lancashire
city: Hinckley
country: United Kingdom
state: Leicestershire
city: Wells-Next-The-Sea
country: United Kingdom
state: Norfolk
city: Wymondham
country: United Kingdom
state: Norfolk
city: Antrim
country: United Kingdom
state: North Ireland
city: Antrim
country: United Kingdom
state: North Ireland
city: Antrim
country: United Kingdom
state: North Ireland
city: Tyrone
country: United Kingdom
state: North Ireland
city: Wellingborough
country: United Kingdom
state: Northamptonshire
city: Chipping Norton
country: United Kingdom
state: Oxfordshire
city: Eccles
country: United Kingdom
state: Sheffield
city: Bath
country: United Kingdom
state: Somerset
city: Barry
country: United Kingdom
state: SOuth Glamorgan
city: Doncaster
country: United Kingdom
state: South Yorkshire
city: Sheffield
country: United Kingdom
state: South Yorkshire
city: Chapelhall
country: United Kingdom
state: Stratchclyde
city: Glasgow
country: United Kingdom
state: Stratchclyde
city: Hamilton
country: United Kingdom
state: Stratchclyde
city: Johnstone
country: United Kingdom
state: Stratchclyde
city: Motherwell
country: United Kingdom
state: Stratchclyde
city: Bury Saint Edmonds
country: United Kingdom
state: Suffolk
city: Bury St. Edmunds
country: United Kingdom
state: Suffolk
city: Bury St. Edmunds
country: United Kingdom
state: Suffolk
city: Hadleigh
country: United Kingdom
state: Suffolk
city: Stowmarket
country: United Kingdom
state: Suffolk
city: Addlestone
country: United Kingdom
state: Surrey
city: East Horsley
country: United Kingdom
state: Surrey
city: Worcester Park
country: United Kingdom
state: Surrey
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne And Wear
city: Coventry
country: United Kingdom
state: Warwickshire
city: Coventry
country: United Kingdom
state: Warwickshire
city: Rugby
country: United Kingdom
state: Warwickshire
city: Coventry
country: United Kingdom
state: West Midlands
city: Brighton
country: United Kingdom
state: West Sussex
city: Crawley
country: United Kingdom
state: West Sussex
city: Crawley
country: United Kingdom
state: West Sussex
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Bradford-on-Avon
country: United Kingdom
state: Wiltshire
city: Chippenham
country: United Kingdom
state: Wiltshire
city: Chippenham
country: United Kingdom
state: Wiltshire
city: Corsham
country: United Kingdom
state: Wiltshire
city: Trowbridge
country: United Kingdom
state: Wiltshire
city: Westbury
country: United Kingdom
state: Wiltshire
city: Aberdeen
country: United Kingdom
city: Airedire
country: United Kingdom
city: Antrim
country: United Kingdom
city: Bath
country: United Kingdom
city: Bath
country: United Kingdom
city: Belfast
country: United Kingdom
city: Belfast
country: United Kingdom
city: Belfast
country: United Kingdom
city: Belfast
country: United Kingdom
city: Belfast
country: United Kingdom
city: Belfast
country: United Kingdom
city: Belfast
country: United Kingdom
city: Belfast
country: United Kingdom
city: Bellshill
country: United Kingdom
city: Blantyre
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Coatrbridge
country: United Kingdom
city: Crossgar
country: United Kingdom
city: Doncaster
country: United Kingdom
city: Dundee
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Hamilton
country: United Kingdom
city: Hamilton
country: United Kingdom
city: Inverness
country: United Kingdom
city: Ipswich
country: United Kingdom
city: Lockerbie
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: New Stevenson
country: United Kingdom
city: Paisley
country: United Kingdom
city: Peterborough
country: United Kingdom
city: Thornhill
country: United Kingdom
city: Watford
country: United Kingdom
city: Wishaw
country: United Kingdom
city: Witley Bay
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Gaziano JM, Brotons C, Coppolecchia R, Cricelli C, Darius H, Gorelick PB, Howard G, Pearson TA, Rothwell PM, Ruilope LM, Tendera M, Tognoni G; ARRIVE Executive Committee. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet. 2018 Sep 22;392(10152):1036-1046. doi: 10.1016/S0140-6736(18)31924-X. Epub 2018 Aug 26.