Randomized, double-blind trial comparing the effects of a 3-month clopidogrel regimen, combined with ASA during the first month, versus ASA alone for the acute treatment of patients with TIA or minor stroke - CASTIA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2400

Inclusion Criteria

1) Male or female > or = 40 years
2) TIA (> or = 10 minutes) or minor acute ischemic stroke (NIHSS < or = 3 at time of randomization) that can be treated with study drug within 24 hours of symptoms onset
3) Informed consent signed
4) Brain MRI scan performed within 24 hours of symptoms onset and prior to randomization

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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