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
Study Type
INTERVENTIONAL
Purpose
PREVENTION
Enrollment
1,295
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
Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Time frame: Up to 124 weeks
Number of Patients With Brain (Cerebral) Haemorrhage
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Time frame: Up to 124 weeks
Number of Patients With Subarachnoid Haemorrhage
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Time frame: Up to 124 weeks
Number of Patients With Transient Ischemic Attack (TIA)
All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.
Time frame: Up to 124 weeks
Number of Patients With Acute Coronary Syndrome (ACS)
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.
Time frame: Up to 124 weeks
Number of Patients With Other Vascular Events
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.
Time frame: Up to 124 weeks
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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
...and 141 more locations
Number of Patients With Ischemic Vascular Event Composite Endpoint
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.
Time frame: Up to 124 weeks