JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme

Completed

Phase 3 Results

Trial Description

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

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Aggrenox (Aggrenox)Drug
    Intervention Desc: Aspirin and Extended-Release Dipyridamole decreases the risk of stroke in patients who have had a stroke or transient ischemic attack (known as a 'TIA' or 'mini-stroke') by helping to prevent dangerous blood clots from forming. Generic aspirin-dipyridamole combinations are not available.
  • Aggrenox capsule Drug
    Intervention Desc: extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily
    ARM 1: Kind: Experimental
    Label: Aggrenox Capsule
  • Acetylsalicylic Acid (ASA) Drug
    Intervention Desc: Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily
    ARM 1: Kind: Experimental
    Label: Acetylsalicylic Acid (ASA) 81 mg Tablet

Trial Design

  • Purpose: Prevention
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized into two groups receiving either combination drug containing extended-release dipyridamole 200 mg/ASA 25 mg twice daily or ASA 81 mg once daily.

Outcomes

Type Measure Time Frame Safety Issue
Primary Recurrence of brain infarction (fatal or non-fatal).
Secondary Brain hemorrhage, subarachnoid hemorrhage, transient ischemic attack (TIA), ACS (MI, angina unstable or cardiac death), and other vascular events.
Primary Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) Up to 124 weeks No
Secondary Number of Patients With Brain (Cerebral) Haemorrhage Up to 124 weeks No
Secondary Number of Patients With Subarachnoid Haemorrhage Up to 124 weeks No
Secondary Number of Patients With Transient Ischemic Attack (TIA) Up to 124 weeks No
Secondary Number of Patients With Acute Coronary Syndrome (ACS) Up to 124 weeks No
Secondary Number of Patients With Other Vascular Events Up to 124 weeks No
Secondary Number of Patients With Ischemic Vascular Event Composite Endpoint Up to 124 weeks No

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