The purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.
Trial Stopped: Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.
- Aspirin (stroke prevention) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Clopidogrel (Plavix®)Drug
Other Names: Plavix, Clodelib, Clovelen Intervention Desc: Antiplatelet agent
- EXANTA Drug
Other Names: Ximelagatran
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety Study
- Intervention: Parallel Assignment
Patients will be randomly assigned to one of 2 types of treatment-either aspirin alone or the combination of aspirin and clopidogrel. In addition, participants with hypertension will be randomly assigned to one of 2 groups of blood pressure control.
|Type||Measure||Time Frame||Safety Issue|
|Primary||To find out if using aspirin and clopidogrel together is more effective than using aspirin alone to prevent recurrent stroke in patients with lacunar stroke.|
|Secondary||To find out if lowering a patient's blood pressure below the usual limits will also help prevent recurrent stroke and maintain thinking ability. To find out if using the drugs together is more effective than using aspirin alone.|
|Primary||Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.|
- AstraZeneca Lead