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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00818753
Other study ID # 1160.73
Secondary ID 2007-007536-25
Status Completed
Phase Phase 2
First received January 7, 2009
Last updated June 3, 2014
Start date January 2009

Study information

Verified date December 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Netherlands: Central Committee Research Involving Human Subjects
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
dabigatran 110 mg
comparison of different dabigatran dosages with unfractionated heparin
dabigatran 150 mg
comparison of different dabigatran dosages with unfractionated heparin
unfractionated heparin
comparison of different dosages dabigatran with unfractionated heparin

Locations

Country Name City State
Netherlands 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

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis Investigator reported outcome From 22 to 165 minutes No
Secondary Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy Investigator reported outcome From 22 to 165 minutes No
Secondary Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow Investigator reported outcome From 22 to 165 minutes No
Secondary Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis Investigator reported outcome From 22 to 165 minutes No
Secondary 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). First administration until 7-14 days after PCI (Percutaneous Coronary Intervention) Yes
See also
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