NCT01361763

Safety Study of Dabigatran in CADASIL

Phase II, Randomized, Crossover, Single Blind, Safety Trial of DABIGATRAN Versus ASA for Preventing Ischaemic Brain Lesions in Patients Affected by CADASIL

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: S. Andrea Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary endpoint is the number of microbleeds, as measured by MRI, at 90 days of follow up. The study is based on the hypothesis that drugs inhibitor of the thrombin is more effective than ASA in preventing vessel obstruction. The rationale behind the study is based on the assumption that: a) the formation of microthrombi is relevant to the clinical expression of the CADASIL disease, and b) thrombin inhibitors are more effective than antiplatelet drugs in preventing lesions by microvessel obstruction. Eligible patients will be randomized into one of the 2 treatment groups: 1. One week wash-out (W1), Dabigatran one tablet 100mg twice a day for 12 weeks, a second one week wash-out (W2), treatment with ASA one tablet of 100mg/day once a day for 12 weeks; 2. The same scheme repeated with reversed sequence No initial wash-out week will be required for patients in group 2 already treated with ASA. Clinical and instrumental evaluations will be carried out during the first (W1) and second wash-out weeks (W2), and at the end of the study (during the week that follows the second treatment regimen (W3). Each evaluation will consist of physical examination, blood tests and MRI. Safety is evaluated on the basis of brain microbleeds and severe haemorrhages.

Conditions

• CADASIL

Interventions

Type	Name	Description
DRUG	Dabigatran	110 mg twice daily
DRUG	Antiplatelets	100mg once a day

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2011-05-27
• Last updated: 2014-02-11

Locations

2 sites across 1 country: Italy