Using a protocol to manage antithrombotic medicines around surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic interventional trial randomizes patients on chronic antithrombotic therapy to protocol-based perioperative management versus routine care to compare a composite of perioperative outcomes. Eligible patients are those taking antiplatelet and/or anticoagulant drugs for cardiovascular or cerebrovascular disease and meeting high-risk criteria who are scheduled for surgery. The protocol is based on multidisciplinary guideline and expert-consensus recommendations and standardizes timing of drug withholding, bridging, and resumption. Outcomes include perioperative bleeding, thrombotic events, and other perioperative complications collected at a single tertiary hospital site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Patients with continuing antithrombotic therapy (including antiplatelet and/or anticoagulant therapies) for cardiovascular and cerebrovascular diseases for more than 2 weeks.
* 2\. Patients who have one or more of the following situations: (1) non-valvular atrial fibrillation with a CHA2DS2-VASc score \>4; (2) post-artificial valve replacement (including mitral valve, ball-cage valve or tilting disc aortic valve); (3) venous thromboembolism occurred within 1 year, or venous thromboembolism with other high-risk factors which require long-term anticoagulation treatment; (4) coronary heart disease with coronary stent implantation, thrombolytic therapy or other coronary procedures within 2 years, or who had undergone coronary artery bypass grafting within 1 year, or who experienced myocardial infarction or acute coronary syndrome within 1 year; (5) a history of stroke/transient ischemic accident within 1 year, or a history of cervical or intracranial revascularization treatment within 1 year; (6) peripheral arterial disease.
* 3\. Patients who are scheduled to undergo intra-abdominal surgery (including general and urologic surgery).
* 4\. Patients who sign written informed consents.

Exclusion Criteria:

* 1\. Refuse to participate.
* 2\. Emergency surgery.
* 3\. Unable to complete the preoperative assessment and follow-up plan.
* 4\. Other reasons that are considered unsuitable for study participation by the investigators or the attending doctors.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Hong Zhang — Peking University First Hospital
• Study coordinator: Hong Zhang, MD
• Email: zhanghong40@hotmail.com
• Phone: 86 10 83572784

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.