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Helping people who have had heart stents who are having surgeries that aren't related to the heart, using Perioperative Bridging Therapy

Not Applicable
Conditions
Clinical benefits and risks of discontinuing antiplatelet drugs with LMWH bridging therapy in patients with coronary stents undergoing noncardiac surgery
Surgery
Registration Number
ISRCTN65203415
Lead Sponsor
Chinese PLA General Hospital
Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38649992/ (added 24/04/2024)

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
2476
Inclusion Criteria

1. 75 years of age or older
2. Underwent PCI with stents >12 months
3. Had received antiplatelet therapy for 1 year or longer
4. Were undergoing elective surgery or other elective invasive procedure that required interruption of antiplatelet therapy

Exclusion Criteria

1. Less than 75 years of age
2. Have taken antiplatelet therapy for less than 12 months
3. Were scheduled for local anesthesia surgery, planned cardiac surgery
4. Major cardiac ischemic events and/or bleeding within the previous 6 weeks
5. Patients with a mechanical heart valve, some of whom were receiving both oral anticoagulant therapy and antiplatelet therapy
6. Platelet count of less than 100×1^3 per cubic millimeter.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary efficacy outcome:<br>Composite of major adverse cardiac or cerebrovascular events, defined as myocardial injury, myocardial infarction, cardiac death and non-fatal stroke measured using patient records at the end of the study<br><br>Primary safety outcome:<br>Major bleeding defined by one or more of the events defined by the International Society on Thrombosis and Haemostasis measured using patient records at the end of the study
Secondary Outcome Measures
NameTimeMethod
Secondary efficacy outcomes:<br>Pulmonary embolism, deep-vein thrombosis and death measured using patient records at the end of the study<br><br>Secondary safety outcome:<br>Minor bleeding measured using patient records at the end of the study
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