Heart CatheterizationPhase 2NCT00818753

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

A Phase 2 study testing dabigatran 110 mg, dabigatran 150 mg and unfractionated heparin in people with Heart Catheterization, run by Boehringer Ingelheim at 4 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Heart Catheterization
What is being tested?: dabigatran 110 mg, dabigatran 150 mg and unfractionated heparin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 4 sitesNetherlands
Study dates: Jan 2009to Aug 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

1160.73.31004 Boehringer Ingelheim Investigational Site
Alkmaar
1160.73.31003 Boehringer Ingelheim Investigational Site
Nieuwegein
1160.73.1 Boehringer Ingelheim Investigational Site
Rotterdam
1160.73.31002 Boehringer Ingelheim Investigational Site
Rotterdam

Other trials in Netherlands

About this study

Official title: The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization

Conditions: Heart Catheterization
Being tested: dabigatran 110 mg, dabigatran 150 mg, unfractionated heparin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00818753
Study group	Role	What they receive
Dabigatran 110 mg	Experimental	experimental drug therapy in this indication Receives: Drug: dabigatran 110 mg
Dabigatran 150 mg	Experimental	experimental drug therapy in this indication Receives: Drug: dabigatran 150 mg
Unfractionated Heparin	Active comparator	standard therapy in this indication as comparator Receives: Drug: unfractionated heparin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis
Investigator reported outcome
Measured: From 22 to 165 minutes

Secondary outcomes (4)

Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy
Investigator reported outcome
Measured: From 22 to 165 minutes
Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow
Investigator reported outcome
Measured: 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
Measured: 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).
Measured: First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Aug 2010

First posted8 Jan 2009 (estimated)
Study startJan 2009
Primary completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Heart CatheterizationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00818753
Sponsor's protocol ID: 1160.73
Other IDs: 2007-007536-25
Status last verified: Dec 2013
First submitted: 7 Jan 2009
Last updated: 9 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 23182947

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Heart Catheterization trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization
ClinicalTrials.gov ID: NCT00818753
Acronym / sponsor ID: 1160.73
Conditions: Heart Catheterization
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Aug 2010 (actual)
First posted: 8 Jan 2009 (estimated)
Results: Posted 25 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dabigatran 110 mg	Experimental	Drug: dabigatran 110 mgexperimental drug therapy in this indication
Dabigatran 150 mg	Experimental	Drug: dabigatran 150 mgexperimental drug therapy in this indication
Unfractionated Heparin	Active comparator	Drug: unfractionated heparinstandard therapy in this indication as comparator

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dabigatran 110 mgcomparison of different dabigatran dosages with unfractionated heparin	Drug	Dabigatran 110 mg
dabigatran 150 mgcomparison of different dabigatran dosages with unfractionated heparin	Drug	Dabigatran 150 mg
unfractionated heparincomparison of different dosages dabigatran with unfractionated heparin	Drug	Unfractionated Heparin

Primary outcome

Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis
Time frame: From 22 to 165 minutes
Investigator reported outcome

4 secondary outcomes

Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy
Time frame: From 22 to 165 minutes
Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow
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
Time frame: From 22 to 165 minutes
Number of Participants With Bleeding Events
Time frame: First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)

Results and safety

Results posted to the registry on 25 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran 110mg Bis in Die (BID)	22	19
Dabigatran 150mg Bis in Die (BID)	21	21
Heparin	10	9

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

Time frame: From 22 to 165 minutes. Number. Unit: Percentage of participants

Measure	Dabigatran 110mg Bis in Die (BID) n = 19	Dabigatran 150mg Bis in Die (BID) n = 21	Heparin n = 10
Value	10.5 (10.5)	14.3 (14.3)	10.0 (10)

Dabigatran 110mg Bis in Die (BID) vs Heparin: Odds Ratio (OR): 1.00 (95% CI 0.08 to 12.76), Cochran-Mantel-Haenszel
Dabigatran 150mg Bis in Die (BID) vs Heparin: Odds Ratio (OR): 1.50 (95% CI 0.13 to 16.82), Cochran-Mantel-Haenszel

Population analysed: Full analysis set (FAS). All patients who were treated with randomised medication and underwent a cardiac intervention

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: First administration until 7-14 days after PCI (Percutaneous Coronary Intervention). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran 110mg Bis in Die (BID)	1 of 20 (5%)	4 of 20 (20%)	Not reported
Dabigatran 150mg Bis in Die (BID)	0 of 21 (0%)	3 of 21 (14.3%)	Not reported
Heparin	0 of 10 (0%)	3 of 10 (30%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23182947Vranckx 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.
Related InfoLink provided by the sponsor.

Related trials for Heart Catheterization

Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Novel Wearable Device for Heart Failure Management
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RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
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RecruitingObservational study
Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
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RecruitingObservational study
Artificial Intelligence-assisted Evaluation of Pulmonary HYpertension
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dabigatran 110 mg, dabigatran 150 mg and unfractionated heparin in people with Heart Catheterization, run by Boehringer Ingelheim at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis (time frame: From 22 to 165 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00818753, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.