Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stable Angina; Myocardial Infarction
Intervention: clopidogrel (SR25990) (Drug); ticlopidine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Takaaki Issiki, PhD/FACC, Principal Investigator, Affiliation: Division of Cardiology, Dpt of Medicine, Teikyo University
Overall contact:
Public Registry ICD, Email: GV-contact-us@sanofi-aventis.com
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
Clinical Details
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 design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Safety Events of interest
Secondary outcome: Major Adverse Cardiac Events (MACE) and Major Adverse Cardiac and Cerebrovascular Events (MACCE)Bleeding events Adverse Events /Adverse Drug Reactions
Detailed description:
After Week 12, one tablet of clopidogrel 75 mg will be administered once daily until Week 52
in a patients' subset(long-term open label phase).
All patients should receive aspirin (81-100 mg once daily) as a background therapy during
investigational product administration.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Stable Angina / Old Myocardial Infarction patients who meet all of the following
criteria:
- Myocardial ischemic finding is 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 is 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.
Locations and Contacts
Public Registry ICD, Email: GV-contact-us@sanofi-aventis.com
Sanofi-aventis Administrative Office, Tokyo, Japan; Recruiting
Additional Information
Starting date: December 2008
Ending date: August 2010
Last updated: October 1, 2009
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