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Safety Study of Dabigatran in CADASIL (SONICA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by S. Andrea Hospital.
Recruitment status was:  Recruiting
Information provided by:
S. Andrea Hospital Identifier:
First received: May 16, 2011
Last updated: February 10, 2014
Last verified: December 2013
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.

Condition Intervention Phase
Drug: Dabigatran
Drug: Antiplatelets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Crossover, Single Blind, Safety Trial of DABIGATRAN Versus ASA for Preventing Ischaemic Brain Lesions in Patients Affected by CADASIL

Resource links provided by NLM:

Further study details as provided by S. Andrea Hospital:

Primary Outcome Measures:
  • Number of microbleeds on MRI [ Time Frame: Six Months ]
    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.

Secondary Outcome Measures:
  • Major bleeding [ Time Frame: Six Months ]
    Severe haemorrhages are defined as a reduction of the haemoglobin level by at least 20g per litre, need of a transfusion of at least 2 units of blood, or symptomatic bleeding of an organ or critical area. Life threatening haemorrhages are a subcategory of severe hemorrhages defined as: fatal haemorrhages, symptomatic intracranial haemorrhages, haemorrhages with a diminution of haemoglobin level of at least 50g per litre or that require transfusion of at least 4 blood units, or surgery. All the other haemorrhages are considered minor.

Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran Drug: Dabigatran
110 mg twice daily
Active Comparator: Antiplatelets Drug: Antiplatelets
100mg once a day

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01361763

Contact: Francesco Orzi, MD +3933775829
Contact: Giulio Caselli, MD 3478654946

Emergency Department Stroke Unit, Umberto I Hospital Not yet recruiting
Rome, Italy, 00161
Contact: Danilo Toni, MD    +39-06-49979595   
Contact: Agata Correnti, MD         
Principal Investigator: Emanuele Puca, MD         
NESMOS Department St. Andrea Hospital Recruiting
Rome, Italy, 00189
Contact: Francesco Orzi, MD    +39-06-33775829   
Contact: Giulio Caselli, MD    +39-347-8654946   
Principal Investigator: Giulio Caselli, MD         
Principal Investigator: Barbara Casolla, MD         
Sponsors and Collaborators
S. Andrea Hospital
Study Chair: Francesco Orzi, MD NESMOS Department, University of Rome "La Sapienza"; St. Andrea Hospital
  More Information


Responsible Party: Francesco Orzi, Department of Neuroscience, Mental Healt and Sensory Organs (NESMOS); University of Rome "La Sapienza" Identifier: NCT01361763     History of Changes
Other Study ID Numbers: DABCAD2010
Study First Received: May 16, 2011
Last Updated: February 10, 2014

Keywords provided by S. Andrea Hospital:
Small Vessel Disease

Additional relevant MeSH terms:
Dementia, Multi-Infarct
Dementia, Vascular
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, Inborn
Cerebral Infarction
Brain Infarction
Brain Ischemia
Neurocognitive Disorders
Mental Disorders
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on April 24, 2017