Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

Summary

This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

Conditions

• Stroke
• Secondary Prevention

Interventions

DRUG

optional ASA as comedication

optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.

DRUG

placebo to ASA

placebo to comparator drug

DRUG

placebo to optional ASA as comedication

optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.

DRUG

placebo to dabigatran etexilate

placebo

DRUG

ASA 100 mg

active comparator drug

DRUG

dabigatran etexilate

active drug

Sponsors & Collaborators

• Boehringer Ingelheim

  lead INDUSTRY

Principal Investigators

• Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

150 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-27

Primary Completion

2018-08-14

Completion

2018-08-14

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Canada
• Chile
• China
• Colombia
• Croatia
• Czechia
• Estonia
• France
• Germany
• Greece
• Hong Kong
• Hungary
• India
• Israel
• Italy
• Japan
• Malaysia
• Mexico
• New Zealand
• Peru
• Poland
• Portugal
• Russia
• Serbia
• Singapore
• Slovakia
• Slovenia
• South Africa
• South Korea
• Spain
• Sweden
• Switzerland
• Taiwan
• Thailand
• Turkey (Türkiye)
• Ukraine

Study Locations