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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

Impact of Perioperative Bridging Therapy on clinical events of elderly patients with prior coronary stents implanted >1 year undergoing non-cardiac surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN65203415
Enrollment
2500
Registered
2023-12-12
Start date
2023-01-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical benefits and risks of discontinuing antiplatelet drugs with LMWH bridging therapy in patients with coronary stents undergoing noncardiac surgery Surgery

Interventions

Patients were randomly assigned using an online tool to receive LMWH bridging therapy with dalteparin sodium (2500 IU administered subcutaneously twice daily) or to receive no bridging therapy (a matc

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Primary efficacy outcome: 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 Primary safety outcome: 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

MeasureTime frame
Secondary efficacy outcomes: Pulmonary embolism, deep-vein thrombosis and death measured using patient records at the end of the study Secondary safety outcome: Minor bleeding measured using patient records at the end of the study

Countries

China

Contacts

Public ContactLinggen Gao
chenleighcpl@163.com+86 15801612879

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026