JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Intervention: Aggrenox capsule; Acetylsalicylic Acid (ASA)
Intervention description: extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily; Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily
Intervention MeSH terms: Aspirin; Aspirin, Dipyridamole Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Parallel Assignment
Enrollment: 1295.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

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) twice daily vs. acetylsalicylic acid 81 mg once daily
    

Eligibility criteria:

        Inclusion Criteria:

        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.

          1. 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)

          2. Patients who are 50 years or older

          3. Patients whose neurological signs and symptoms are considered to be stable by the
             investigator or sub-investigator

          4. Patients with a finding corresponding to the responsible focus confirmed by head X-ray
             computerised tomography (CT) or magnetic resonance imaging (MRI)

          5. 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 Criteria:

          1. 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

          2. Patients with complications of cardiac disorders (atrial fibrillation, mitral valve
             stenosis, severe cardiac valve disorders) that may provide an embolic source for
             cerebral embolism

          3. Patients having had acute coronary syndromes (acute myocardial infarction, unstable
             angina) within 6 months after enrolment in this study

          4. Patient with hypersensitivity to dipyridamole preparations

          5. Patients with a history of drug allergy to acetylsalicylic acid (ASA) or aspirin
             asthma

          6. Patients with a history of peptic ulcer

          7. Patients having undergone arterial reconstruction after development of cerebral
             infarction

          8. Patients with very severe impairment (4 or 5 on Modified Rankin Scale)

          9. Patients with bleeding or bleeding tendencies (haemophilia, haemorrhage urinary tract,
             vitreous haemorrhage, etc.)

         10. Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher or
             diastolic blood pressure is 110 mmHg or higher)

         11. Patients with complications such as serious cardiac, renal and hepatic disorders

         12. Patients with a malignant tumour or having had a tumour treatment in the past 5 years

         13. Women who are or may be pregnant or lactating women