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JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme
This study is ongoing, but not recruiting participants.
First Received: March 28, 2006   Last Updated: April 22, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00311402
  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
Drug: ASA 81 mg tablet
Phase III

Drug Information available for: Acetylsalicylic acid TX 3301
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Parallel Assignment
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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Recurrence of brain infarction (fatal or non-fatal) [ Time Frame: 52 weeks to 124 weeks ]

Secondary Outcome Measures:
  • Brain hemorrhage Subarachnoid hemorrhage Transient ischemic attack (TIA) Acute coronary syndromes (myocardial infarction, angina unstable, cardiac death) Other vascular events [ Time Frame: 52 weeks to 124 weeks ]

Estimated Enrollment: 1250
Study Start Date: April 2006
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
  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 CT or 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 (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 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311402

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

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 9.178
Study First Received: March 28, 2006
Last Updated: April 22, 2009
ClinicalTrials.gov Identifier: NCT00311402     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Anti-Inflammatory Agents
Cerebral Infarction
Cyclooxygenase Inhibitors
Stroke
Vascular Diseases
Central Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Agents
Ischemia
Brain Diseases
Cerebrovascular Disorders
Recurrence
Fibrin Modulating Agents
Aspirin
Analgesics, Non-Narcotic
Brain Ischemia
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Brain Infarction
Antirheumatic Agents
Infarction
Dipyridamole

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

ClinicalTrials.gov processed this record on May 07, 2009