NCT02240953

Brief Summary

Prosthetic valve thrombosis is a serious complication with high mortality and morbidity. However, the best anticoagulant treatment strategies for patients with prosthetic heart valve thrombosis have not been fully known. In this study the investigators wanted to identify the most effective and safe regimen among different anticoagulant regimens.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

5.9 years

First QC Date

September 12, 2014

Last Update Submit

September 15, 2014

Conditions

Thrombosis

Keywords

AnticoagulationProsthetic Heart ValvesAcetylsalicylic acidWarfarinThrombosis

Outcome Measures

Primary Outcomes (4)

  • Decreased thrombus size

    Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications

    6 months

  • Same thrombus size

    Thrombus size remains as similar as the previous transesophageal echocardiographic examination findings in the absence of any fatal and non fatal major complications

    6 months

  • Increased thrombus size

    Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications

    6 months

  • Complications

    Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion Nonfatal minor complication: Bleeding without need for transfusion, TIA.

    6 months

Study Arms (4)

Warfarin

ACTIVE COMPARATOR

In the first arm only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis

Drug: Warfarin

Warfarin + ASA 100 mg + PPI

ACTIVE COMPARATOR

In the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis

Drug: Warfarin + ASA 100 mg + PPI

Warfarin + ASA 300 mg + PPI

ACTIVE COMPARATOR

In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis

Drug: Warfarin + ASA 300 mg + PPI

Observational Warfarin

ACTIVE COMPARATOR

This arm is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4.

Drug: Observational Warfarin

Interventions

WarfarinDRUG

Only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis

Warfarin
Warfarin + ASA 100 mg + PPIDRUG

100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis

Warfarin + ASA 100 mg + PPI
Warfarin + ASA 300 mg + PPIDRUG

In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis

Warfarin + ASA 300 mg + PPI
Observational WarfarinDRUG

This is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4.

Observational Warfarin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with prosthetic heart valve thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosuyolu Kartal Heart Training and Research Hospital

Istanbul, 34844, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Thrombosis

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD., Prof., Head of Cardiology

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 16, 2014

Study Start

January 1, 2009

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

TU(1)