Safety Study of Dabigatran in CADASIL

NCT01361763 | Unknown Phase 2 DMC

• 1 other identifier: DABCAD2010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

CADASIL

Keywords

Dabigatran; Microbleeds; Microthrombi; CADASIL; Small Vessel Disease

Outcome Measures

Primary Outcomes (1)

• Number of microbleeds on MRI

  Primary endpoint is defined as the difference in number of microbleeds on MRI images taken at the end of the 2 treatments (i.e, during W2 and W3). Secondary endpoint is major bleeding. The neuroradiologists (or trained neurologists) who will examine the images on MRI will be blind to treatment.

  Six Months

Secondary Outcomes (1)

• Major bleeding

  Six Months

Study Arms (2)

Dabigatran

EXPERIMENTAL

Drug: Dabigatran

Antiplatelets

ACTIVE COMPARATOR

Drug: Antiplatelets

Interventions

Dabigatran DRUG

110 mg twice daily

Dabigatran

Antiplatelets DRUG

100mg once a day

Antiplatelets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• S. Andrea Hospital: lead

Study Sites (2)

Emergency Department Stroke Unit, Umberto I Hospital

Rome, Rome, 00161, Italy

NOT YET RECRUITING

NESMOS Department St. Andrea Hospital

Rome, Rome, 00189, Italy

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

CADASIL

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Small Vessel Diseases; Dementia, Vascular; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Dementia; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Francesco Orzi, MD

  NESMOS Department, University of Rome "La Sapienza"; St. Andrea Hospital

  STUDY CHAIR

Central Study Contacts

Francesco Orzi, MD

CONTACT

+3933775829; francesco.orzi@uniroma1.it

Giulio Caselli, MD

CONTACT

3478654946; giulio.caselli@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 27, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 11, 2014

Record last verified: 2013-12

Locations

IT (2)