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Aspirin Withdrawal and Clinical Outcome in Patients With Moderate to High Cardiovascular Risk But Without Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT03757156
Recruitment Status : Not yet recruiting
First Posted : November 28, 2018
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

While the efficacy of aspirin for the secondary prevention of cardiovascular disease is evident, the effect of aspirin for primary prevention is unclear. The use of aspirin reduces cardiovascular mortality and myocardial infarction but increases side effects such as bleeding. Therefore, the use of aspirin for primary prevention in people without cardiovascular disease should be determined by individual risk and clinical benefit. The European guidelines have been changed to not recommend aspirin use in people without cardiovascular disease, but there are still people taking aspirin for primary prevention. The purpose of this study is to investigate the effect of aspirin withdrawal on cardiovascular events in patients without cardiovascular disease.

This is a single center, prospective, randomized clinical study evaluating the safety and efficacy of withdrawal of aspirin among patients with moderate or high cardiovascular risk.


Condition or disease Intervention/treatment Phase
Healthy Participants With Moderate and High Cardiovascular Risk Other: Withdrawal of aspirin Not Applicable

Detailed Description:
Patients taking aspirin will be randomly assigned to a group that maintains taking aspirin and a group that discontinues to take aspirin by 1:1 manner. The follow-up duration is five years and clinical outcomes will be investigated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Aspirin maintenance group versus aspirin interruption group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Aspirin Withdrawal and Clinical Outcome in Patients With Moderate to High Cardiovascular Risk But Without Cardiovascular Disease
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
No Intervention: Aspirin maintenance group
People who are taking aspirin continue to take aspirin.
Experimental: Aspirin withdrawal group
People who are taking aspirin stop to taking aspirin.
Other: Withdrawal of aspirin
People who are taking aspirin stop to taking aspirin.




Primary Outcome Measures :
  1. Major adverse cardiovascular events(MACE) [ Time Frame: 5 years ]
    Major adverse cardiovascular events is composite endpoint. It includes cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft), nonfatal ischemic stroke, and transient ischemic attack.


Secondary Outcome Measures :
  1. cardiovascular death [ Time Frame: 5 years ]
    Individual component of primary endpoint

  2. nonfatal myocardial infarction [ Time Frame: 5 years ]
    Individual component of primary endpoint

  3. nonfatal ischemic stroke [ Time Frame: 5 years ]
    Individual component of primary endpoint

  4. coronary revascularization [ Time Frame: 5 years ]
    Individual component of primary endpoint

  5. transient ischemic attack [ Time Frame: 5 years ]
    Individual component of primary endpoint

  6. Bleeding [ Time Frame: 5 years ]
    Major bleeding is defined with International Society on Thrombosis and Haemostasis (ISTH) criteria: 1) fatal bleeding; 2)Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; 3) bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfuction of two or more units of whole blood or red cells. Bleeding that is not classified as major bleeding is minor.



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults aged 19-80 years old
  • Subjects who are taking for more than 12 months
  • Subjects with moderate or high cardiovascular risk based on cardiovascular risk classification of 2015 Korea Society of Lipidology And Atherosclerosis guideline or 2004 American Heart Association guideline: 1) moderate risk: people with ≥2 major risk factors, 2) high risk: people with carotid atherosclerosis, abdominal aortic aneurysm, or diabetes, who is taking statin
  • Subjects who voluntarily participate in the study and sign informed consent form

Exclusion Criteria:

  • Subjects with a history of major cardiovascular disease confirmed by medical history and medical history; myocardial infarction, angina pectoris, coronary angioplasty, coronary artery bypass surgery, peripheral vascular disease, ischemic stroke, transient ischemic attack
  • Subjects has any contraindication to use of aspirin or hypersensitivity to aspirin
  • Subjects with atrial fibrillation
  • Subjects who are taking anti-platelet agents other than aspirin or anticoagulants
  • Subjects who have been diagnosed with cancer within the last 5 years
  • Pregnant women or those who have pregnancy plan after enrolling in this study

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): NCT03757156


Locations
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Korea, Republic of
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine Not yet recruiting
Seoul, Korea, Republic of, 03722
Contact: Sang-Hak Lee, MD    82-2-2228-8460    SHL1106@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Publications:
Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Løchen ML, Löllgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23.

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03757156     History of Changes
Other Study ID Numbers: 4-2018-0910
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
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