null - FindTrial

RANDOMIZED, DOUBLE-BLIND, EVALUATION IN SECONDARY STROKE PREVENTION COMPARING THE EFFICACY AND SAFETY OF THE ORAL THROMBIN INHIBITOR DABIGATRAN ETEXILATE (110 MG OR 150 MG, ORAL B.I.D.) VERSUS ACETYLSALICYLIC ACID (100 MG ORAL Q.D.) IN PATIENTS WITH EMBOLIC STROKE OF UNDETERMINED SOURCE (RESPECT ESUS)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-011-15

Enrollment

Registered

2015-08-18

Start date

2015-08-31

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Test product(s): Dabigatran etexilate (DE) doses: 110 mg and 150 mg twice daily (b.i.d.) mode of admin.: Oral kir containing 4 botles with 60 capsules Comparator products: Acetylsalicylic

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Age ≥ 60 years or: Age 50-59 years plus at least one of the following additional risk factors for stroke: a) Mild to moderate heart failure, i.e. NYHA Class ≤ 3 with left ventricular ejection fraction ≤ 40% as documented by e.g. echocardiogram, radionuclide or contrast angiogram in the last 6 months b) Diabetes mellitus (either type 1 or type 2) c) Hypertension requiring medical treatment with antihypertensive medication d) Patent foramen ovale3 with no interventional occlusion planned e) Prior stroke or TIA (before index stroke) f) CHA2DS2-VASc score ≥ 3 (see Appendix 10.1) The rest of the information is registered in the protocol

Exclusion criteria

Exclusion criteria: 1. Modified Rankin Scale of >4 at time of randomization or inability to swallow medications. 2. Major risk cardioembolic source of embolism such as: a. intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography, b. paroxysmal1, persistent or permanent AF, c. atrial flutter, d. prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical), e. atrial myxoma f. other cardiac tumors, g. moderate or severe mitral stenosis, h. recent (< 4weeks) MI, i. valvular vegetations, or j. infective endocarditis. 3. Any indication that requires treatment with an anticoagulant as per Investigator`s judgment The rest of the information is registered in the protocol

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, France, Germany, Hungary, India, Italy, Japan, Korea South, Mexico, New Zealand, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United States

Contacts

Public ContactElizabeth Rospigliosi

INVENTIV HEALTH CLINICAL PERU S.A

elizabeth.rospigliosi@inventivhealth.com994009328

Outcome results