ABRIDGE: Low Molecular Weight Heparin in Bridging Patients After Mechanical Valve Replacement

Completed · Phase 4

Conditions studied: Mechanical Valve Replacement, Warfarin Therapy

In brief

The primary aim is to determine the rate of major bleeding and blood clots when using enoxaparin as a bridge to oral blood thinning medication in patients who have undergone mechanical valve replacement.

Key facts

Study ID

NCT00298285

Run by

The Cleveland Clinic

People needed

100

Expected to finish

2006-10-01

Last updated by the study team

2007-11-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients meeting all the following will be considered for enrollment.
• Male or non-pregnant female (negative pregnancy test is required for women of child bearing potential) ≥ 18 of age who are able to provide informed consent and able to self-administer enoxaparin.
• Body weight ≥ 45kg and ≤ 150kg.
• Patients who are post prosthetic mechanical valve surgery and will need oral anticoagulation after discharge from the hospital.
• One who has undergone valve replacement with mechanical prosthesis in the mitral position.
• One who has undergone valve replacement with mechanical prosthesis in the aortic position.
• One who has undergone valve replacement with mechanical prosthesis in the tricuspid position.

You may not qualify if…

• Patients with any of the following will not be eligible for enrollment in the study:
• Contraindication or sensitivity to unfractionated heparin/ low molecular weight heparin: history of heparin associated thrombocytopenia, heparin induced thrombocytopenia, or heparin induced thrombotic thrombocytopenia syndrome;
• History of, or current, cardiogenic shock;
• Active endocarditis (requiring > 4 weeks of antibiotics);
• Active bleeding or bleeding diathesis;
• History of gastrointestinal bleeding and /or endoscopically verified ulcer disease within the last three months;
• Known proliferative diabetic retinopathy or history of intraocular bleeding;
• Ischemic stroke in the previous three months or any hemorrhagic stroke, known brain tumor, intracranial aneurysm or intracranial AV malformation;
• Renal insufficiency (cr clearance < 30 cc/min), cr clearance calculation:
• Women = 0.85 x (140 - age) x body weight (kg) / 72 x serum creat (mg/dl), Men = (140 - age) x body weight (kg) / 72 x serum creat (mg/dl), or patient with a renal transplant;
• Anemia (Hgb < 8 gm/dl);
• Thrombocytopenia (platelet count < 100 x 109/L);
• Liver disease demonstrated by ALT > 144u/L
• Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic blood pressure >100mmHg);
• Life expectancy less than 6 months;
• Moderate pericardial effusion as diagnosed by echo;
• Concomitant use of clopidogrel, or cyclooxygenase 1 or 2 inhibitors or use within seven days;
• Non- medical exclusion
• Patients unable or unwilling to provide consent.
• Patients unable or unwilling to have follow-up echocardiogram.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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