N/A
Completed N=748
D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement
Heart Valve Disease
Source: ClinicalTrials.gov NCT01996657 ↗
Enrolled (actual)
748
Serious AEs
7.2%
Results posted
Jun 2017
Primary outcomePrimary: Bleeding Events; — 16; 3; 4 Participants
Summary
The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.
This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bleeding Events; |
16; 3; 4 | — |
| PRIMARY Thrombotic Events |
5; 5; 14 | — |
| SECONDARY All Cause Deaths |
12; 4; 5 | — |
Eligibility Criteria
Inclusion Criteria
- age>18years,male or female without pregnancy;
- Suffered the mechanical valves replacement in Wuhan Asia Heart Hospital;
- The operation type was Mitral valve replacement or Double valves replacement(aortic and mitral valve replacement).
Exclusion Criteria: Patients with following diseases within 3 months.
- deep venous thromboembolism
- Pulmonary embolism
- Aortic dissection
- stroke
- Cerebral hemorrhage
- Myocardial infarction
Data sourced from ClinicalTrials.gov (NCT01996657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.