REDUCE: Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy

• Sponsor: Wuhan Asia Heart Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03885180
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.3
• Patients Per Site Per Month: 20.5

Study Details

Study Description

Brief Summary

Guidelines recommended that patients with bioprosthetic heart valves (BHV) only need 6 months oral anticoagulation therapy after operation. However, a small part of patients still suffered thrombotic events after withdrawal of warfarin, which means these patients may need extend anticoagulation therapy. D-dimer, a sensitive marker of thrombosis or prethromboembolism state. Previous studies have demostrated that patients with elevated D-dimer levels have significant more clinical outcomes than those with nagative D-dimer levels. The aim of this study was to evaluate whether D-dimer could guide the duration of oral anticoagulation therapy in patients with BHV.

Condition or Disease	Intervention/Treatment	Phase
Valve Heart Disease; Anticoagulants; Increased	Drug: Warfarin Sodium	N/A

Detailed Description

Patients with BHV were screened and enrolled in this study. D-dimer levels were measured in the sixth months after BHV operation but before withdrawal of warfarin. Patients with elevated D-dimer were randomized to extend anticoagulation therapy group and routine stopping anticoagulation group.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized Evaluation of D-dimer Guiding Duration of Oral Anticoagulation Therapy in Patients With Bioprosthetic Heart Valves
• Actual Study Start Date: Mar 20, 2019
• Anticipated Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Mar 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Extend anticoagulation group Extended the duration anticoauglation to 12 months	Drug: Warfarin Sodium; Extending warfarin anticoagulation
No Intervention: Stop anticoagulation group Just stop oral anticoagulation like routine

Outcome Measures

Primary Outcome Measures

1. Thrombotic events [24 months]

   Stroke, DVT, PE, valve thrombosis

2. Bleeding events [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients received BHV within 3 months

Exclusion Criteria:

• Recently throboemblism within 6 months

• Recently bleedings within 3 months

• Evaluated lifetime less than 2 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wuhan Asia Heart Hospital	Wuhan	Hubei	China	430022

Sponsors and Collaborators

• Wuhan Asia Heart Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Litao Zhang, MD, Head of anticoagulation clinic, Wuhan Asia Heart Hospital
• ClinicalTrials.gov Identifier: NCT03885180
• Other Study ID Numbers: 2019-P-026
• First Posted: Mar 21, 2019
• Last Update Posted: Mar 26, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Litao Zhang, MD, Head of anticoagulation clinic, Wuhan Asia Heart Hospital: bioprosthetic heart valves; oral anticoagulation; thrombotic events
• Additional relevant MeSH terms: Heart Diseases; Heart Valve Diseases; Warfarin

Study Results

No Results Posted as of Mar 26, 2019