Safety Study of Dabigatran in CADASIL (SONICA)
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ClinicalTrials.gov Identifier: NCT01361763 |
Recruitment Status : Unknown
Verified December 2013 by S. Andrea Hospital.
Recruitment status was: Recruiting
First Posted : May 27, 2011
Last Update Posted : February 11, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
CADASIL | Drug: Dabigatran Drug: Antiplatelets | Phase 2 |
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:
- 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;
- 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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (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 |
Study Start Date : | June 2011 |
Estimated Primary Completion Date : | January 2015 |
Estimated Study Completion Date : | February 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Dabigatran |
Drug: Dabigatran
110 mg twice daily |
Active Comparator: Antiplatelets |
Drug: Antiplatelets
100mg once a day |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361763
Contact: Francesco Orzi, MD | +3933775829 | francesco.orzi@uniroma1.it | |
Contact: Giulio Caselli, MD | 3478654946 | giulio.caselli@gmail.com |
Italy | |
Emergency Department Stroke Unit, Umberto I Hospital | Not yet recruiting |
Rome, Italy, 00161 | |
Contact: Danilo Toni, MD +39-06-49979595 danilo.toni@uniroma1.it | |
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 francesco.orzi@uniroma1.it | |
Contact: Giulio Caselli, MD +39-347-8654946 giulio.caselli@gmail.com | |
Principal Investigator: Giulio Caselli, MD | |
Principal Investigator: Barbara Casolla, MD |
Study Chair: | Francesco Orzi, MD | NESMOS Department, University of Rome "La Sapienza"; St. Andrea Hospital |
Publications:
Responsible Party: | Francesco Orzi, Department of Neuroscience, Mental Healt and Sensory Organs (NESMOS); University of Rome "La Sapienza" |
ClinicalTrials.gov Identifier: | NCT01361763 |
Other Study ID Numbers: |
DABCAD2010 |
First Posted: | May 27, 2011 Key Record Dates |
Last Update Posted: | February 11, 2014 |
Last Verified: | December 2013 |
Dabigatran Microbleeds Microthrombi CADASIL Small Vessel Disease |
CADASIL Dementia, Multi-Infarct 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 Infarction Ischemia Pathologic Processes Necrosis Neurocognitive Disorders Mental Disorders Dabigatran Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |