JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme

Phase 3

Completed

• Conditions: Cerebrovascular Accident
• Interventions: Drug: Aggrenox capsule; Other: Acetylsalicylic Acid (ASA)

• Registration Number: NCT00311402
• Lead Sponsor: Boehringer Ingelheim

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) twice daily vs. acetylsalicylic acid 81 mg once daily

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-28
• Study Start: 2006-04
• Study First Submitted QC: 2006-04-04
• Study First Posted: 2006-04-06
• Primary Completion: 2009-03
• Results First Submitted: 2010-02-16
• Results First Submitted QC: 2010-02-16
• Results First Posted: 2010-03-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1295

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aggrenox Capsule	Aggrenox capsule	-
Acetylsalicylic Acid (ASA) 81 mg Tablet	Acetylsalicylic Acid (ASA)	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)	Up to 124 weeks	All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Ischemic Vascular Event Composite Endpoint	Up to 124 weeks	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.
Number of Patients With Brain (Cerebral) Haemorrhage	Up to 124 weeks	All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Number of Patients With Subarachnoid Haemorrhage	Up to 124 weeks	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)	Up to 124 weeks	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)	Up to 124 weeks	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	Up to 124 weeks	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.

Trial Locations

Locations (151)

9.178.060 Boehringer Ingelheim Investigational Site; 🇯🇵 Adachi-ku, Tokyo, Japan

9.178.017 Boehringer Ingelheim Investigational Site; 🇯🇵 Adumino, Nagano, Japan

9.178.032 Boehringer Ingelheim Investigational Site; 🇯🇵 Akashi, Hyogo, Japan

9.178.074 Boehringer Ingelheim Investigational Site; 🇯🇵 Akashi, Hyogo, Japan

9.178.062 Boehringer Ingelheim Investigational Site; 🇯🇵 Ako, Hyogo, Japan

9.178.064 Boehringer Ingelheim Investigational Site; 🇯🇵 Aoba-ku, Yokohama, Kanagawa, Japan

9.178.097 Boehringer Ingelheim Investigational Site; 🇯🇵 Aoi-ku, Shizuoka, Shizuoka, Japan

9.178.056 Boehringer Ingelheim Investigational Site; 🇯🇵 Asahi, Chiba, Japan

9.178.067 Boehringer Ingelheim Investigational Site; 🇯🇵 Asahikawa, Hokkaido, Japan

9.178.117 Boehringer Ingelheim Investigational Site; 🇯🇵 Asahikawa, Hokkaido, Japan

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9.178.060 Boehringer Ingelheim Investigational Site

🇯🇵Adachi-ku, Tokyo, Japan