Status:
Trial complete. Results published in July of 2004.
Purpose:
To determine whether the combination of clopidogrel plus acetylsalicylic acid (ASA) is superior to clopidogrel alone in preventing ischemic events in patients with a recent TIA or ischemic stroke.
Location(s):
Australia, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Lithuania, the Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States of America.
Year Finished:
2002
Design:
International, randomized, double-blind, prospective, parallel-group trial with a planned enrollment of 7600 patients.
Inclusion Criteria
Patients who experienced ischemic stroke or TIA within 3 months of trial entry and also have at least one additional risk factor (prior ischemic stroke, myocardial infarction (MI), angina pectoris, diabetes mellitus, symptomatic peripheral arterial disease (PAD)).
Exclusion Criteria
Women of childbearing potential and persons who have severe comorbid conditions, inadequately controlled hypertension, severe renal dysfunction or insufficiency, increased risk of bleeding, a history of thrombocytopenia, neutropenia, low platelet, or low neutrophil count, who have any planned carotid endarterectomy, carotid angioplasty, percutaneous coronary anigoplasty, peripheral angioplasty, or any planned major surgery requiring prolonged study drug interruption, who have current or anticipated requirement for oral anticoagulation, an unwillingness to discontinue current antiplatelet treatments, a history of allergy, intolerance, or contra-indication to the use of acetylsalicylic acid or clopidogrel, who have received investigational treatment within the previous 30 days, previously entered into the study, or who are unable to comprehend and provide written informed consent, will be excluded from the study.
Patient Involvement:
Patients will be randomized to receive ASA 75 mg or placebo once per day. Both groups will receive clopidogrel 75 mg once per day. Patients will be treated for 18 months with follow-up visits at 1 month, 3 months, 6 months, 12 months and 18 months, in addition to regular phone calls between visits.
Primary Outcome:
Composite incidence of ischemic stroke, MI, vascular death, and rehospitalization for an acute ischemic event.
Secondary Outcome:
Any death, any stroke, modified Rankin scale (MRS) assessment, life-threatening bleeding events, all bleeding events, other adverse events.
Results:
Compared to clopidogrel 75 mg alone, clopidogrel plus acetylsalicylic acid (ASA) 75 mg had no significant effect on recurrent ischemic events.
15.7% of patients taking clopidogrel + ASA had a further ischemic event vs 16.73% of patients taking clopidogrel + placebo (p=.244). Patients taking clopidogrel + ASA also experienced significantly more life-threatening hemorrhage compared to patients taking clopidogrel + placebo (2.6% vs 1.3%, p<0.001).
Source of Information:
Correspondence with trial coordinator. Presented at the 28th International Stroke Conference (February 2003). Presented at the 13th European Stroke Conference (May 2004). Lancet. 2004; 364: 331-337.
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