JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00311402
First received: March 28, 2006
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Cerebrovascular Accident
Drug: Aggrenox capsule
Other: Acetylsalicylic Acid (ASA)
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme, 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) [ Time Frame: Up to 124 weeks ] [ Designated as safety issue: No ]
    All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.


Secondary Outcome Measures:
  • Number of Patients With Brain (Cerebral) Haemorrhage [ Time Frame: Up to 124 weeks ] [ Designated as safety issue: No ]
    All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

  • Number of Patients With Subarachnoid Haemorrhage [ Time Frame: Up to 124 weeks ] [ Designated as safety issue: No ]
    All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

  • Number of Patients With Transient Ischemic Attack (TIA) [ Time Frame: Up to 124 weeks ] [ Designated as safety issue: No ]
    All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

  • Number of Patients With Acute Coronary Syndrome (ACS) [ Time Frame: Up to 124 weeks ] [ Designated as safety issue: No ]
    ACS contains acute myocardial infarction (MI), unstable angina and sudden cardiac death. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

  • Number of Patients With Other Vascular Events [ Time Frame: Up to 124 weeks ] [ Designated as safety issue: No ]
    This endpoints were defined as pulmonary embolism, retinal vascular disorder, deep vein thrombosis, peripheral artery obstruction and vascular intervention. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

  • Number of Patients With Ischemic Vascular Event Composite Endpoint [ Time Frame: Up to 124 weeks ] [ Designated as safety issue: No ]
    This is a composite endpoint of cerebral infarction, transient ischemic attack (TIA), acute myocardial infarction (MI), unstable angina and sudden death attributable to thromboembolism. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.


Enrollment: 1295
Study Start Date: April 2006
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Aggrenox Capsule Drug: Aggrenox capsule
extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily
Acetylsalicylic Acid (ASA) 81 mg Tablet Other: Acetylsalicylic Acid (ASA)
Acetylsalicylic Acid (ASA) 81 mg, 1 tablet once daily

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311402

  Show 151 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00311402     History of Changes
Other Study ID Numbers: 9.178
Study First Received: March 28, 2006
Results First Received: February 16, 2010
Last Updated: January 21, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Aspirin, dipyridamole drug combination
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014