NCT00818753

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 25, 2011

Completed
Last Updated

June 9, 2014

Status Verified

December 1, 2013

Enrollment Period

1.6 years

First QC Date

January 7, 2009

Results QC Date

August 5, 2011

Last Update Submit

June 3, 2014

Conditions

Heart Catheterization

Outcome Measures

Primary Outcomes (1)

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

    Investigator reported outcome

    From 22 to 165 minutes

Secondary Outcomes (4)

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

    From 22 to 165 minutes

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

    From 22 to 165 minutes

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

    From 22 to 165 minutes

  • Number of Participants With Bleeding Events

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

Study Arms (3)

Dabigatran 110 mg

EXPERIMENTAL

experimental drug therapy in this indication

Drug: dabigatran 110 mg

Dabigatran 150 mg

EXPERIMENTAL

experimental drug therapy in this indication

Drug: dabigatran 150 mg

Unfractionated Heparin

ACTIVE COMPARATOR

standard therapy in this indication as comparator

Drug: unfractionated heparin

Interventions

dabigatran 110 mgDRUG

comparison of different dabigatran dosages with unfractionated heparin

Dabigatran 110 mg
dabigatran 150 mgDRUG

comparison of different dabigatran dosages with unfractionated heparin

Dabigatran 150 mg
unfractionated heparinDRUG

comparison of different dosages dabigatran with unfractionated heparin

Unfractionated Heparin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

1160.73.31004 Boehringer Ingelheim Investigational Site

Alkmaar, Netherlands

Location

1160.73.31003 Boehringer Ingelheim Investigational Site

Nieuwegein, Netherlands

Location

1160.73.1 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

1160.73.31002 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

Related Publications (1)

  • Vranckx P, Verheugt FW, de Maat MP, Ulmans VA, Regar E, Smits P, ten Berg JM, Lindeboom W, Jones RL, Friedman J, Reilly P, Leebeek FW. A randomised study of dabigatran in elective percutaneous coronary intervention in stable coronary artery disease patients. EuroIntervention. 2013 Jan 22;8(9):1052-60. doi: 10.4244/EIJV8I9A162.

    PMID: 23182947DERIVED

MeSH Terms

Interventions

DabigatranHeparin

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlycosaminoglycansPolysaccharidesCarbohydrates

Limitations and Caveats

Although a total of 50 patients are included in the FAS, 4 of these patients did not have data for the primary endpoint and are therefore not included in the odd ratio calculation

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2010

Last Updated

June 9, 2014

Results First Posted

October 25, 2011

Record last verified: 2013-12

Locations

NL(4)