Safety Study of Dabigatran in CADASIL

• Status: Unknown status
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a Phase II, randomized, crossover trial designed to compare one fixed dose of dabigatran with open-label use of ASA in patients affected by CADASIL; the study is a safety trial, and the primary objective is to assess that dabigatran is not less safe than ASA in subjects with CADASIL.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: S. Andrea Hospital
• Treatments: Dabigatran

Criteria

Inclusion Criteria:

• Patients aged 18 years or older diagnosed with CADASIL according genetic test will be eligible.

Exclusion Criteria:

• Treatment with antiplatelet drugs for a condition different from CADASIL;

• conditions associated with an increased risk of bleeding (major surgery within the previous month, planned surgery or intervention within the next 3 months;

• history of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding;

• gastrointestinal hemorrhage within the past year;

• symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days; hemorrhagic disorder or bleeding diathesis;

• need for anticoagulant treatment of disorders other than atrial fibrillation; fibrinolytic agents within 48 hours of study entry; uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg and/or diastolic blood pressure greater than 100 mm Hg);

• recent malignancy or radiation therapy (within 6 months) and not expected to survive 3 years; severe renal impairment (estimated creatinine clearance 30 mL/min or less);

• active infective endocarditis;

• active liver disease (including but not limited to persistent ALT, AST, Alk Phos greater than twice the upper limit of the normal range; active hepatitis C (positive HCV RNA);

• active hepatitis B (HBs antigen +, anti HBc IgM +), active hepatitis A);

• women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study.