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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02797548
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Antiplatelet Drugs Drug: Aspirin only Drug: No antiplatelet therapy Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery
Actual Study Start Date : March 16, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin only Drug: Aspirin only
Aspirin only during surgery

Active Comparator: No antiplatelet therapy Drug: No antiplatelet therapy
No antiplatelet therapy will be during surgery




Primary Outcome Measures :
  1. Composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. All cause death [ Time Frame: 30 days ]
  2. Cardiac death [ Time Frame: 30 days ]
  3. Myocardial infarction [ Time Frame: 30 days ]
  4. Stroke [ Time Frame: 30 days ]
  5. Stent thrombosis [ Time Frame: 30 days ]
  6. Repeat revascularization [ Time Frame: 30 days ]
  7. Life threatening bleeding [ Time Frame: 30 days ]
  8. Major bleeding [ Time Frame: 30 days ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797548


Contacts
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Contact: Seung-jung Park, MD +82230104812 sjpark@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Seung-Jung Park, MD       sjpark@amc.seoul.kr   
Principal Investigator: Seung-Jung Park, MD         
Soon Chun Hyang University Hospital Cheonan Recruiting
Cheonan, Korea, Republic of
Contact: Se-whan Lee, MD       Lovelee93@hanmail.net   
Principal Investigator: Se-whan Lee, MD         
Gangwon National Univ. Hospital Not yet recruiting
Chuncheon, Korea, Republic of
Contact: Bong-Ki Lee, MD       mdbklee@kangwon.ac.kr   
Principal Investigator: Bong-Ki Lee, MD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jae-whan Lee, MD       myheart@cnu.ac.kr   
Principal Investigator: Jae-whan Lee, MD         
Kangbuk Samsung Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jong-young Lee, MD       jyleeheart@naver.com   
Principal Investigator: Jong-young Lee, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea

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Responsible Party: Seung-Jung Park, professor of medicine, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02797548     History of Changes
Other Study ID Numbers: AMCCV2016-10
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seung-Jung Park, Asan Medical Center:
drug-eluting stent
antiplatelet therapy
noncardiac surgery
Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics