Status:
COMPLETED
JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Cerebrovascular Accident
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twi...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of cerebral infarction (excluding cardiogenic cerebral embolism) who meet the diagnostic criteria based on the National Institute of Neurological Disorders and Stroke (NINDS) ad hoc committee's classification of cerebrovascular disease III.
- Patients who have had an onset of cerebral infarction, the time of which is known, between 1 week and 6 months before the time of enrolment (including first and recurrent cerebral infarctions)
- Patients who are 50 years or older
- Patients whose neurological signs and symptoms are considered to be stable by the investigator or sub-investigator
- Patients with a finding corresponding to the responsible focus confirmed by head X-ray computerised tomography (CT) or magnetic resonance imaging (MRI)
- Patients who have at least two of the following risk factors:
- diabetes
- hypertension (systolic blood pressure is 140 mmHg or higher or diastolic blood pressure is 90 mmHg or higher) or under treatment of hypertension
- smoker (at the time of onset of cerebral infarction)
- obesity (Body mass index (BMI) is more than 25 kg/m2)
- previous vascular disease (stroke, acute myocardial infarction or peripheral arterial disease before the onset of cerebral infarction)
- end-organ damage (retinopathy, left ventricular hypertrophy (LVH) or microalbuminuria)
- hyperlipidaemia
Exclusion
- Patients with a diagnosis of brain disorders with a bleeding risk such as brain haemorrhage, subarachnoid haemorrhage, cerebral arteriovenous (AV) malformation, cerebral AV aneurysms and brain tumours
- Patients with complications of cardiac disorders (atrial fibrillation, mitral valve stenosis, severe cardiac valve disorders) that may provide an embolic source for cerebral embolism
- Patients having had acute coronary syndromes (acute myocardial infarction, unstable angina) within 6 months after enrolment in this study
- Patient with hypersensitivity to dipyridamole preparations
- Patients with a history of drug allergy to acetylsalicylic acid (ASA) or aspirin asthma
- Patients with a history of peptic ulcer
- Patients having undergone arterial reconstruction after development of cerebral infarction
- Patients with very severe impairment (4 or 5 on Modified Rankin Scale)
- Patients with bleeding or bleeding tendencies (haemophilia, haemorrhage urinary tract, vitreous haemorrhage, etc.)
- Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher or diastolic blood pressure is 110 mmHg or higher)
- Patients with complications such as serious cardiac, renal and hepatic disorders
- Patients with a malignant tumour or having had a tumour treatment in the past 5 years
- Women who are or may be pregnant or lactating women
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1295 Patients enrolled
Trial Details
Trial ID
NCT00311402
Start Date
April 1 2006
Last Update
February 14 2014
Active Locations (151)
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1
9.178.060 Boehringer Ingelheim Investigational Site
Adachi-ku, Tokyo, Japan
2
9.178.017 Boehringer Ingelheim Investigational Site
Adumino, Nagano, Japan
3
9.178.032 Boehringer Ingelheim Investigational Site
Akashi, Hyogo, Japan
4
9.178.074 Boehringer Ingelheim Investigational Site
Akashi, Hyogo, Japan