Myocardial Infarction, Stable Angina
Conditions
Keywords
Old Myocardial infarction, Platelet Aggregation Inhibitors, Angioplasty, Transluminal, Percutaneous Coronary, Stents
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.
Interventions
Form: tablets Route: oral
DRUGticlopidine
Form: tablets Route: oral
DRUGPlacebo
Form: tablets Route: oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from randomization to first safety events of interest | 12 Weeks (duble blind treatment period) | Safety events of interest were: * Clinically significant bleeding, * Leukopenia, neutropenia or thrombocytopenia occurring as adverse drug reaction, * Elevated liver function values occurring as adverse drug reaction, * Permanent investigational product discontinuation due to skin disorders, gastrointestinal disorders, bleeding, hepatic disorders, or significant decreases in such tests as leukocytes, neutrophils or platelets occurring as adverse drug reaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from randomization to first Major Adverse Cardiac Events (MACE) | 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period) | MACE included: * All- cause mortality, * Acute myocardial infarction, * Revascularization (excluding revascularization related to the planned PCI), * Stent thrombosis |
| Time from randomization to first bleeding events | 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period) | — |
| Time from randomization to first Adverse Events / Adverse Drug Reactions | 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) | 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period) | MACCE included: * All- cause mortality, * Acute myocardial infarction, * Revascularization (excluding revascularization related to the planned PCI), * Stent thrombosis, * Ischemic stroke. |
Countries
Japan
Outcome results
None listed