the acute treatment of patients with TIA or minor stroke MedDRA version: 8.1 Level: HLT Classification code 10008192
Conditions
Interventions
Trade Name: PLAVIX
Product Name: clopidogrel
Product Code: SR25990C
Pharmaceutical Form: Tablet
INN or Proposed INN: clopidogrel
Current Sponsor code: SR25990C
Concentration unit: mg milligram(s)
Conc
Sponsors
Sanofi-Aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female > or = 40 years 2) TIA (> or = 10 minutes) or minor acute ischemic stroke (NIHSS =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Related to absolute contraindications to the use of clopidogrel and/or ASA: 1) History of drug allergy to thienopyridine derivatives or ASA 2) Severe uncontrolled hypertension despite treatment at the time of randomization 3) History of clinically significant or persistent thrompocytopenia 4) History of clinically significant or persistent neutropenia 5) Women of child-bearing potential who are not following an effective method of contraception 6) Women who are breast-feeding 7) Other contra-indication to the use of ASA (severe renal or hepatic insufficiency, severe cardiac failure, asthma) Related to concomitant or planned medication(s) / treatment(s): 8) Absolute indication for the use of open-label clopidogrel, ticlopidine, GPIIb IIIa receptor antagonists, thrombolytics, heparin therapy or oral anticoagulation. 9) Use of thrombolysis within 24 hours prior to randomization. 10) Current treatment (last dose given within 10 days before randomization) with GPIIb IIIa receptor antagonists, , heparin therapy or oral anticoagulation. 11) Absolute indication for higher dose of ASA (>75 mg/day) or ASA + dipyridamole 12) Current or planned daily treatment with NSAIDs 13) Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months (if clinically indicated, vascular imaging should be performed prior to randomization whenever possible.) Related to TIA/Stroke characteristics: 14) Diagnosis of hemorrhage, vascular malformation, tumor, abscess, or other major non-ischemic brain disease (e.g., multiple sclerosis plaque, major developmental anomaly) on baseline brain MRI 15) Pure sensory symptoms, pure vertigo or dizziness, or pure visual loss without evidence of acute infarction on MRI 16) Modified Rankin Score >2 at randomization 17) NIH Stroke Scale Score >3 at randomization 18) Presumed cardiac source of embolus (e.g. atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis) Related to the presence of other medical problems that would either interfere with participation in the trial or lead to inability to complete the trial: 19) Increased risk of bleeding, such as severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding (e.g. gastrointestinal bleeding, gross hematuria, intraocular bleeding, symptomatic hemorrhagic stroke, or intracranial hemorrhage), or other history of bleeding diathesis or coagulopathy 20) Concomitant (or within previous month) myocardial infarction or unstable angina 21) Presence of a severe co-morbid condition such that the patient is not expected to survive 1 year or which could interfere with the assessment of outcomes 22) Scheduled for surgery requiring study drug cessation 23) Receipt of any investigational treatment (drug or device) within the previous 30 days 24) Geographic or social factors making study participation impractical 25) Patient unable to understand the full meaning of the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300mg followed by 75mg/day combined with ASA 75mg/day during the first month versus a 3-month regimen of ASA 75mg/day alone on reducing the occurrence of new ischemic vascular events (clinical ischemic stroke, new ischemic infarction on brain MRI, myocardial infarction, or vascular death) in patients with acute TIA/minor stroke;Secondary Objective: To assess separately the effects of this clopidogrel regimen versus ASA alone on the incidence of: - New clinical ischemic vascular events (ischemic stroke/MI/vascular death) as a cluster and evaluated individually - New cerebral infarction(s) assessed by MRI To evaluate change in modified Rankin scale (continuous) and percentage with score 0-2 at last follow-up. To compare the safety of the two treatment regimens in terms of: - Severe or moderate bleeding (GUSTO definition) - Cerebral bleeding - Total mortality - AEs/SAEs To compare efficacy and safety by qualifying event, TIA vs. stroke. To compare efficacy and safety by time to randomization, 12 h. In further exploratory analysis, to evaluate change in NIHSS score and cognitive function among survivors. ;Primary end point(s): Primary efficacy endpoint: - Percentage of patients with a new ischemic vascular event, defined as any event of the following cluster: o New cerebral infarction on brain MRI o New clinical ischemic stroke o MI o Vascular death | — |
Countries
Hungary, Portugal, Spain, United Kingdom
Outcome results
None listed