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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
Sponsor:
Information provided by:
S. Andrea Hospital

May 16, 2011
May 27, 2011
February 11, 2014
June 2011
January 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01361763 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
CADASIL
  • Drug: Dabigatran
    110 mg twice daily
  • Drug: Antiplatelets
    100mg once a day
  • Experimental: Dabigatran
    Intervention: Drug: Dabigatran
  • Active Comparator: Antiplatelets
    Intervention: Drug: Antiplatelets

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
Same as current
February 2015
January 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01361763
DABCAD2010
Yes
Not Provided
Not Provided
Francesco Orzi, Department of Neuroscience, Mental Healt and Sensory Organs (NESMOS); University of Rome "La Sapienza"
S. Andrea Hospital
Not Provided
Study Chair: Francesco Orzi, MD NESMOS Department, University of Rome "La Sapienza"; St. Andrea Hospital
S. Andrea Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP