RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Coronary Disease

Treatments: Drug: placebo; Drug: dabigatran etexilate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00621855

1160.67

RE-DEEM (Other Identifier)

2007-004301-99 (EudraCT Number)

Details and patient eligibility

About

The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.

Enrollment: 1,878 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria Patients with acute coronary syndromes with at least one additional risk factor for cardiovascular complications.

Exclusion criteria

1. Long term treatment with any other oral anticoagulant
2. Severe/disabling stroke within last 6 months
3. Conditions associated with increased bleeding risk
4. Anaemia or thrombocytopenia
5. Severe renal impairment
6. Liver disease
7. Positive pregnancy test

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,878 participants in 5 patient groups, including a placebo group

Dabigatran etexilate 50mg

Experimental group

Description:

twice daily dosing,

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Dabigatran etexilate 75mg

Experimental group

Description:

twice daily dosing, patients with moderate renal impairment allocated 50mg bid

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Dabigatran etexilate 110mg

Experimental group

Description:

twice daily dosing, patients with moderate renal impairment allocated 75mg bid

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

dabigatran etexilate 150mg

Experimental group

Description:

twice daily dosing, patients with moderate renal impairment allocated 110mg bid

Treatment:

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

Drug: dabigatran etexilate

placebo

Placebo Comparator group

Description:

matched placebo

Treatment:

Drug: placebo