Clinical trial NCT00821834: Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned
Official title: A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg Once Daily With a 300 mg Loading Dose Versus Ticlopidine 100 mg Twice Daily in Patients With Stable Angina or Old (Healed) Myocardial Infarction to Which Percutaneous Coronary Intervention is Being Planned - With Extended Treatment of Clopidogrel 75 mg Once Daily for 40 Weeks in a Patients' Subset
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stable Angina
Myocardial Infarction
Keywords: Old Myocardial infarction
Platelet Aggregation Inhibitors
Angioplasty
Transluminal
Percutaneous Coronary
Stents
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 1003
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary objective:

* To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interest in patients with stable angina (SA) or old myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being planned.

Secondary objectives:

* To compare the incidence of adverse events, adverse drug reactions and bleeding events in patients treated with clopidogrel versus ticlopidine.
* To compare the incidence of major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus ticlopidine.
* To evaluate the long-term safety (adverse drug reactions, adverse events, safety events of interest and bleeding events) of clopidogrel for a total of 52 weeks;
* To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.

Detailed description: The study consisted of two periods:

* a double blind treatment period of 12 weeks followed by,
* an open label clopidogrel treatment period in a subset of patients.

All patients should receive aspirin (81-100 mg once daily) as a background therapy during investigational product administration.

Eligibility criteria: Inclusion Criteria:

Stable Angina / Old Myocardial Infarction patients who met all of the following criteria:

* Myocardial ischemic finding was proven within 2 months before randomization,
* Either ≥ 75% stenosis documented by CAG or severe stenosis confirmed by multi-slice computerized tomography (MSCT) angiography within 1 month before randomization,
* PCI was being planned.

Exclusion Criteria:

* Planned coronary artery bypass graft (CABG), emergent/urgent PCI, or staged PCI,
* 3-vessel coronary artery disease with significant lesions in each vessel,
* Planned PCI associated with 6 or more stent placements,
* Not less than 50% stenosis of the left main coronary artery,
* Chronic total occlusion (CTO),
* Saphenous vein graft (SVG).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Time from randomization to first safety events of interest
timeFrame: 12 Weeks (duble blind treatment period)
Secondary outcomes:
measure: Time from randomization to first Major Adverse Cardiac Events (MACE)
timeFrame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
measure: Time from randomization to first bleeding events
timeFrame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
measure: Time from randomization to first Adverse Events / Adverse Drug Reactions
timeFrame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
measure: Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Division of Cardiology, Dpt of Medicine, Teikyo University
name: Takaaki Issiki, PhD/FACC
role: PRINCIPAL_INVESTIGATOR
References: