Long Term Open Follow-up With H376/95 vs. Warfarin

Terminated

Phase 2 Results N/A

Trial Description

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Trial Stopped: Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • EXANTA Drug
    Other Names: Ximelagatran

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Patient Involvement

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.

Outcomes

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.

Sponsors