Clinical trial NCT01603082: Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients
Official title: A Randomized, Open-label Study to Compare the Platelet Inhibition With VerifyNow Assay of Ticagrelor Versus Clopidogrel in Troponin Negative Acute Coronary Syndrome Subjects Undergoing Ad Hoc Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-05-22
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI

Detailed description: A randomized, open-label, multiple-center, parallel group study to compare the platelet inhibition with VerifyNow assay of ticagrelor versus clopidogrel in troponin negative Acute Coronary Syndrome (ACS) subjects undergoing Ad Hoc percutaneous coronary intervention (PCI)

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent before initiation of any study-related procedures
* Male or female patients aged 18 years or older
* Documented acute coronary syndrome and troponin negative and undergoing Ad Hoc percutaneous coronary intervention (PCI)
* Females must be post menopausal or surgically sterile
* Taking aspirin as an anti-platelet medication

Exclusion Criteria:

* Use of any thienopyridine or ticagrelor within 7 days prior to randomization
* Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve)
* Contraindication that ticagrelor or clopidogrel should not be administered Patient requires dialysis
* History of intolerance or allergy to aspirin

Primary outcomes:
measure: Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™
timeFrame: 2 hours after the loading dose
Secondary outcomes:
measure: Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™
timeFrame: 0.5 hours, end of PCI, and 8 hours after the loading dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: San Francisco
country: United States
facility: Research Site
state: California
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Ypsilanti
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Tupelo
country: United States
facility: Research Site
state: Mississippi
city: North Kansas
country: United States
facility: Research Site
state: Missouri
city: Belleville
country: United States
facility: Research Site
state: New Jersey
city: Bronx
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Tyler
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: AstraZeneca Pharmaceuticals, Wilmington, DE 19850-5437 USA
name: Glenn F. Carlson, MD
role: STUDY_DIRECTOR
References:
citation: Sweeny JM, Angiolillo DJ, Franchi F, Rollini F, Waksman R, Raveendran G, Dangas G, Khan ND, Carlson GF, Zhao Y, Teng R, Mehran R. Impact of Diabetes Mellitus on the Pharmacodynamic Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Acute Coronary Syndrome Patients Undergoing Ad Hoc Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Mar 29;6(4):e005650. doi: 10.1161/JAHA.117.005650.
citation: Angiolillo DJ, Franchi F, Waksman R, Sweeny JM, Raveendran G, Teng R, Zhao Y, Carlson G, Khan N, Mehran R. Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Patients With Low-Risk ACS Undergoing Ad Hoc PCI. J Am Coll Cardiol. 2016 Feb 16;67(6):603-613. doi: 10.1016/j.jacc.2015.11.044.