- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00821834
Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned (CLEAN)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Tokyo, Japan
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clopidogrel
Patients received:
|
Form: tablets Route: oral Form: tablets Route: oral |
Active Comparator: Ticlopidine
Patients received:
|
Form: tablets Route: oral Form: tablets Route: oral |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time from randomization to first safety events of interest
Time Frame: 12 Weeks (duble blind treatment period)
|
Safety events of interest were:
|
12 Weeks (duble blind treatment period)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time from randomization to first Major Adverse Cardiac Events (MACE)
Time Frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
|
MACE included:
|
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
|
Time from randomization to first bleeding events
Time Frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
|
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
|
|
Time from randomization to first Adverse Events / Adverse Drug Reactions
Time Frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
|
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
|
|
Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time Frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
|
MACCE included:
|
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Takaaki Issiki, PhD/FACC, Division of Cardiology, Dpt of Medicine, Teikyo University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Pain
- Neurologic Manifestations
- Chest Pain
- Myocardial Infarction
- Infarction
- Angina Pectoris
- Angina, Stable
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Clopidogrel
- Ticlopidine
Other Study ID Numbers
- EFC10675
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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