Anticoagulant Therapy During Pacemaker Implantation

NCT00479362 | Completed Phase 4

• 3 other identifiers: FINPACTAHD-VARF (Former Protocol ID)TV001
• Study Type: interventional
• Target: 447
• Locations: 1 country
• Sites: 1

Brief Summary

There are no established guidelines regarding interruption of warfarin anticoagulant therapy prior to surgical implantation of cardiac pacemakers. Continuing the anticoagulant could potentially result in increased bleeding complications from the implantation surgery, whereas discontinuing the anticoagulant could predispose the patient to blood clots and strokes. In this study we intend to randomly assign warfarin-treated patients either into interrupted or continued warfarin therapy prior to pacemaker implantation with the purpose of establishing the rate of complication in these groups. Our hypothesis is that a cardiac pacing device can be safely implanted without discontinuation of the anticoagulant therapy.

Conditions

Hemorrhage; Thrombosis; Embolism

Keywords

Pacemaker; Cardioverter-defibrillator; Hemorrhage; Hematoma; Thrombosis; Embolism

Outcome Measures

Primary Outcomes (1)

• Measure: rate of haemorrhagic and thromboembolic complications

  within first four weeks

Study Arms (4)

1 Warfarin Uninterrupted

EXPERIMENTAL

Warfarin therapy is continued without interruption prior to cardiac pacing device implantation

Drug: Warfarin; Device: Permanent pacemaker; Device: Implantable Cardioverter-defibrillator

2 Warfarin Interrupted

ACTIVE COMPARATOR

Warfarin therapy is discontinued 2 days prior to cardiac pacing device implantation

Drug: Warfarin; Device: Permanent pacemaker; Device: Implantable Cardioverter-defibrillator

3 Aspirin Group

SHAM COMPARATOR

Patients with aspirin therapy during implantation

Drug: Aspirin; Device: Permanent pacemaker; Device: Implantable Cardioverter-defibrillator

4 No Antithrombotic Group

OTHER

No antithrombotic treatment during operations

Device: Permanent pacemaker; Device: Implantable Cardioverter-defibrillator

Interventions

Warfarin DRUG

Warfarin is either interrupted or uninterrupted prior to device implantation

Also known as: Marevan, ATC code B01AA03, Marevan Forte, ATC code B01AA03

1 Warfarin Uninterrupted; 2 Warfarin Interrupted

Aspirin DRUG

Aspirin is continued without interruption prior to device implantation

Also known as: Acethyl Salcylic Acid, Primaspan, ATC code B01AC06, Disperin, ATC code B01AC06, Aspirin Cardio, ATC code B01AC06

3 Aspirin Group

Permanent pacemaker DEVICE

Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.

Also known as: Pacing Device Implantation

1 Warfarin Uninterrupted; 2 Warfarin Interrupted; 3 Aspirin Group; 4 No Antithrombotic Group

Implantable Cardioverter-defibrillator DEVICE

Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.

Also known as: ICD

1 Warfarin Uninterrupted; 2 Warfarin Interrupted; 3 Aspirin Group; 4 No Antithrombotic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients admitted for implantation of a first permanent cardiac pacing device are eligible

You may not qualify if:

• known coagulation disorder or bleeding diathesis
• contraindications for pacing device implantation
• mechanical prosthetic heart valve
• other absolute contraindication to interrupt warfarin
• INR (international normalized ratio) above 3.0 2 days prior to implantation
• significant anemia (hemoglobin less than 100 g/L)
• warfarin interrupted before randomization and INR subtherapeutic (below 2.0)
• not to be randomized to venography: contraindications to radiographic contrast dye

Sponsors & Collaborators

• University of Turku: lead
• Satakunta Central Hospital: collaborator
• Oulu University Hospital: collaborator
• Tampere University Hospital: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Hemorrhage; Thrombosis; Embolism; Hematoma

Interventions

Warfarin; Aspirin; Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Juhani Airaksinen, MD

  University of Turku, Turku University Hospital

  STUDY DIRECTOR

• Petri Korkeila, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2007
• First Posted: May 28, 2007
• Study Start: September 1, 2005
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

FI (1)