ow INR to Minimize bleeding with mechanical valves Trial

Phase 3

Recruiting

Conditions: bleeding post-mechanical valve replacement
thromboembolism post-mechanical valve replacement.
10046973

Registration Number: NL-OMON56927

Lead Sponsor: Population Health Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1) Have had a bileaflet mechanical heart valve implant in the aortic position
>=3 months ago,
2) Be >=18 years of age at the time of enrolment,
3) Provide written informed consent (either from the patient or a substitute
decision-maker).

Exclusion Criteria

1) Have a second implanted mechanical valve (any position),
2) Lower boundary of planned INR range is less than 2.0,
3) Pregnant or expecting to become pregnant during the study follow-up.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the incidence of major bleeding.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The most important secondary outcome is all thrombosis/thromboembolism<br /><br>(composite of ischemic stroke, systemic thromboembolism, valve thrombosis).<br /><br>Other secondary outcomes include:<br /><br>1) All-cause mortality (selected rather than cardiovascular mortality, as<br /><br>cause-specific mortality is often difficult to ascertain or define in complex<br /><br>cardiovascular patients in whom multi-end-organ dysfunction may accompany<br /><br>cardiovascular decline)<br /><br>2) All bleeding<br /><br>3) Minor bleeding<br /><br>4) All stroke<br /><br>5) Ischemic stroke<br /><br>6) Hemorrhagic stroke<br /><br>7) Type 1, 2 or 3 myocardial infarction<br /><br>8) Systemic thromboembolism<br /><br>9) Valve thrombosis<br /><br>10) Pulmonary embolism<br /><br>11) Deep vein thrombosis<br /><br>12) New renal replacement therapy<br /><br>13) Time in therapeutic range<br /><br>14) Proportion of patients with extreme INR values (>4)</p><br>