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

Boehringer Ingelheim53 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Catheterization

Interventions

dabigatran 110 mgDRUG

comparison of different dabigatran dosages with unfractionated heparin

dabigatran 150 mgDRUG

comparison of different dabigatran dosages with unfractionated heparin

unfractionated heparinDRUG

comparison of different dosages dabigatran with unfractionated heparin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (4)

1160.73.31004 Boehringer Ingelheim Investigational Site

Alkmaar, Netherlands

1160.73.31003 Boehringer Ingelheim Investigational Site

Nieuwegein, Netherlands

1160.73.1 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

1160.73.31002 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis

Investigator reported outcome

Time frame: From 22 to 165 minutes

Secondary Outcomes

Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy

Investigator reported outcome

Time frame: From 22 to 165 minutes

Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow

Investigator reported outcome

Time frame: From 22 to 165 minutes

Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis

Investigator reported outcome

Time frame: From 22 to 165 minutes

Number of Participants With Bleeding Events

Bleeding is categorized using the TIMI criteria as major or minor bleeding. The time window for inclusion of bleeding events was up until 3 days post-procedure or discharge (whichever occurred first).

Time frame: First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)

Data from ClinicalTrials.gov

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