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NCT Number: NCT02797548

Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery

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.

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Key information

Conditions

Antiplatelet Drugs

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jaslok Hospital, Mumbai, India

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin only

Drug

Aspirin only during surgery

No antiplatelet therapy

Drug

No antiplatelet therapy will be during surgery

Primary outcomes

  1. The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke

    Time frame: 30 days

    A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.

Secondary outcomes

  1. The event rate of all cause death

    Time frame: 30 days

  2. The event rate of cardiac death

    Time frame: 30 days

  3. The event rate of myocardial infarction

    Time frame: 30 days

  4. The event rate of stroke

    Time frame: 30 days

  5. The event rate of stent thrombosis

    Time frame: 30 days

  6. The event rate of repeat revascularization

    Time frame: 30 days

  7. The event rate of life threatening bleeding

    Time frame: 30 days

  8. The event rate of major bleeding

    Time frame: 30 days

  9. Quality of life score assessed by the EQ-5D-5L

    Time frame: 30 days

    The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively.

  10. Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)

    Time frame: 30 days

    HINT-8 was developed based on 4 health dimensions: physical, mental, social, and positive health dimensions. It consists of climbing stairs, endurance to pain, vitality, working, depression, memory, sleep, and happiness.

    Higher score of HINT-8 means the high quality of life. The minimum and maximum values are 0 and 100 respectively if convert to a percentage.

  11. Cost-effective analysis

    Time frame: 30 days

    Cost-effective analysis based on average treatment costs for two perioperative antiplatelet therapy_Aspirin only vs. No antiplatelet therapy_in patients with drug-eluting stent undergoing non-cardiac surgery.

Sponsors and collaborators

Lead sponsor

Jung-min Ahn

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Acronym: ASSURE-DES

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2016
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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