Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned (CLEAN)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Stable Angina; Myocardial Infarction

Treatments: Drug: Placebo; Drug: ticlopidine; Drug: clopidogrel (SR25990)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00821834

EFC10675

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,003 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,003 participants in 2 patient groups

Clopidogrel

Experimental group

Description:

Patients received: * clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose, * ticlopidine matching placebo twice daily.

Treatment:

Drug: clopidogrel (SR25990)

Drug: Placebo

Ticlopidine

Active Comparator group

Description:

Patients received: * ticlopidine 100 mg twice daily, * clopidogrel matching placebo once daily.

Treatment:

Drug: ticlopidine

Drug: Placebo