Clinical trial NCT01327183: A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention
Official title: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF 2 DOSES OF RO4905417 (R1512) ADMINISTERED TO PATIENTS WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NON-STEMI) UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarction
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-01
Enrollment: 532
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI. Follow-up will be for 4 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>18 to \<75 years of age
* Non ST-elevation myocardial infarction
* Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
* Body mass index (BMI) \</= 40 kg/m2

Exclusion Criteria:

* Acute ST-elevation myocardial infarction (STEMI)
* Culprit coronary lesion with a total thrombotic occlusion or a lesion requiring the use of distal embolization protection or thrombectomy devices
* Percutaneous coronary intervention (PCI) within the past 72 hours
* Thrombolytic therapy within the past 7 days
* Major surgery within the past 3 months
* History of cerebral vascular disease or stroke in the past 3 months
* Bleeding disorders
* Inadequately controlled severe hypertension
* Prior coronary artery bypass graft (CABG) surgery
* Decompensated heart failure (oedema and/or rale)
* Acute infection at screening or active chronic infection within 3 months prior to PCI
* Patients known to be HIV positive, patients receiving antiretroviral drugs, or immuno-suppressed patients
* Uncontrolled diabetes mellitus (HbA1C \>10%) at baseline

Primary outcomes:
measure: Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI
timeFrame: from baseline to 24 hours post PCI
Secondary outcomes:
measure: Change from baseline in troponin I at 8 hours post PCI
timeFrame: from baseline to 8 hours post PCI
measure: Peak and AUC for troponin I
timeFrame: 24 hours post PCI
measure: Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI
timeFrame: from baseline to 24 hours post PCI
measure: Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI
timeFrame: from baseline to Day 120 post PCI
measure: Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI
timeFrame: from baseline to Day 30 post PCI
measure: Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs)
timeFrame: 120 days
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Salinas
country: United States
state: California
city: Littleton
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Aurora
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Massachusetts
city: Hyannis
country: United States
state: Massachusetts
city: Bay City
country: United States
state: Michigan
city: Petoskey
country: United States
state: Michigan
city: St. Paul
country: United States
state: Minnesota
city: Ridgewood
country: United States
state: New Jersey
city: Johnson City
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Springfield
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Chambersburg
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: St-Charles Borromee
country: Canada
state: Quebec
city: Heerlen
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Tilburg
country: Netherlands
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
city: Gdynia
country: Poland
city: Jozefow
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Kraków
country: Poland
city: Starogard Gdanski
country: Poland
city: Torun
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wejherowo
country: Poland
city: Wroclaw
country: Poland
city: Łodz
country: Poland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Stahli BE, Gebhard C, Duchatelle V, Cournoyer D, Petroni T, Tanguay JF, Robb S, Mann J, Guertin MC, Wright RS, L L'Allier P, Tardif JC. Effects of the P-Selectin Antagonist Inclacumab on Myocardial Damage After Percutaneous Coronary Intervention According to Timing of Infusion: Insights From the SELECT-ACS Trial. J Am Heart Assoc. 2016 Nov 16;5(11):e004255. doi: 10.1161/JAHA.116.004255.
citation: Tardif JC, Tanguay JF, Wright SR, Duchatelle V, Petroni T, Gregoire JC, Ibrahim R, Heinonen TM, Robb S, Bertrand OF, Cournoyer D, Johnson D, Mann J, Guertin MC, L'Allier PL. Effects of the P-selectin antagonist inclacumab on myocardial damage after percutaneous coronary intervention for non-ST-segment elevation myocardial infarction: results of the SELECT-ACS trial. J Am Coll Cardiol. 2013 May 21;61(20):2048-55. doi: 10.1016/j.jacc.2013.03.003. Epub 2013 Mar 10.