Helping people who have had heart stents who are having surgeries that aren't related to the heart, using Perioperative Bridging Therapy
- Conditions
- Clinical benefits and risks of discontinuing antiplatelet drugs with LMWH bridging therapy in patients with coronary stents undergoing noncardiac surgerySurgery
- 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
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
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
Name Time Method 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
Name Time Method 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