Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery (ASSURE-DES)

Jung-min Ahn

Status and phase: Completed; Phase 4

Conditions: Antiplatelet Drugs

Treatments: Drug: Aspirin only; Drug: No antiplatelet therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02797548

AMCCV2016-10

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of perioperative antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.

Full description

Subjects who can not be randomized due to any reason will be enrolled at observational group.

Enrollment: 1,010 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planned non-cardiac surgery at least after 12 months of implantation of drug eluting stent
• Low or intermediate risk level surgery
• Written informed consent

Exclusion criteria

• Acute coronary syndrome within 1 month
• Heart failure NYHA III to IV
• Contraindication to Aspirin
• On anticoagulant therapy
• Emergent surgery
• Cardiac surgery
• High bleeding risk surgeries, e.g., Intra-cranial surgery, Intra-spinal surgery, Retinal surgery
• Pregnancy or breast-feeding
• Life expectancy less than 1year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,010 participants in 2 patient groups

Aspirin only

Experimental group

Treatment:

Drug: Aspirin only

No antiplatelet therapy

Active Comparator group

Treatment:

Drug: No antiplatelet therapy