Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).

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Detailed Description

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Conditions

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Heart Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dabigatran 110 mg

experimental drug therapy in this indication

Group Type EXPERIMENTAL

dabigatran 110 mg

Intervention Type DRUG

comparison of different dabigatran dosages with unfractionated heparin

Dabigatran 150 mg

experimental drug therapy in this indication

Group Type EXPERIMENTAL

dabigatran 150 mg

Intervention Type DRUG

comparison of different dabigatran dosages with unfractionated heparin

Unfractionated Heparin

standard therapy in this indication as comparator

Group Type ACTIVE_COMPARATOR

unfractionated heparin

Intervention Type DRUG

comparison of different dosages dabigatran with unfractionated heparin

Interventions

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dabigatran 110 mg

comparison of different dabigatran dosages with unfractionated heparin

Intervention Type DRUG

dabigatran 150 mg

comparison of different dabigatran dosages with unfractionated heparin

Intervention Type DRUG

unfractionated heparin

comparison of different dosages dabigatran with unfractionated heparin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients between 18 and 85 years
* due to undergo elective PCI
* informed consent obtained

Exclusion Criteria

* PCI lesion specific conditions
* class III or IV congestive heart failure
* severe hypertension
* increased bleeding risk
* thrombolytic therapy within 24 hours preceding randomization

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No