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A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial

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ClinicalTrials.gov Identifier: NCT03947229
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
The investigators hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (DES) implantation.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease DES Drug: Clopidogrel mono-therapy Drug: Dual-antiplatelet therapy Phase 4

Detailed Description:
Patients at high risk for either ischemic or bleeding complications, but who were stable without clinical events for 12 months after DES implantation will be included in this study. Eligible patients will be randomized to continue DAPT (aspirin plus clopidogrel) for further 24 months or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone). Randomization will be stratified according to 1) clinical presentation (acute coronary syndrome or stable coronary artery disease) and 2) age (≥75 or <75). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative. All of study subjects will be have an outpatient visit as scheduled in outpatient clinic. Occurrence of study endpoints will be documented at clinical visit or telephone interview every 6 months since randomization. Antiplatelet drugs will be open-label and prescribed by attending physician.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be assigned to continue DAPT (aspirin plus clopidogrel) or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone) for further 24 months.
Masking: None (Open Label)
Masking Description: Antiplatelet drugs will be open-label and prescribed by attending physician.
Primary Purpose: Treatment
Official Title: A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clopidogrel mono-therapy
After randomization, patients will receive clopidogrel monotherapy after DES implantation for 24 months.
Drug: Clopidogrel mono-therapy
Patients will receive clopidogrel (75 mg once daily) monotherapy without co-administration of aspirin for 24 months after randomization.

Active Comparator: Dual-antiplatelet therapy
Patients will receive dual antiplatelet consisting of aspirin and clopidogrel.
Drug: Dual-antiplatelet therapy
Patients will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 24 months after randomization.




Primary Outcome Measures :
  1. Net Adverse Clinical Events (NACE) [ Time Frame: 24 months ]
    The composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or bleeding (BARC type 2, 3, or 5)


Secondary Outcome Measures :
  1. Each component of net adverse clinical events [ Time Frame: 24 months ]
  2. All-cause or cardiovascular mortality [ Time Frame: 24 months ]
  3. Major or minor bleeding [ Time Frame: 24 months ]
    Major or minor bleeding would be defined by BARC and TIMI criteria

  4. Major adverse cardiac event [ Time Frame: 24 months ]
    Major Adverse Cardiac events includes all-cause of death, myocardial infarctions, stent thrombosis, or stroke.



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients >19 years old
  2. Patients who underwent DES implantation 12 months (+5 months) previously.
  3. High risk characteristics (clinical or lesion) for ischemic events (must at least one)

High risk patients; clinical criteria

  1. Acute coronary syndrome
  2. Previous history of cerebrovascular accidents
  3. History of peripheral artery intervention
  4. Heart failure (left ventricular ejection fraction ≤40%)
  5. Diabetes treated with medication
  6. Chronic renal insufficiency including end-stage renal diseases

High risk lesions; angiographic or procedural criteria

  1. Left main diseases
  2. Bifurcation lesions
  3. Chronic total occlusion
  4. In-stent restenotic lesions
  5. Graft lesions
  6. Diffuse long lesions requiring total stent length ≥28 mm
  7. Calcified lesions requiring atherectomy
  8. Multivessel coronary artery disease with multiple stents
  9. Small vessel disease requiring stent diameter of ≤2.5 mm

Exclusion Criteria:

  1. Age> 80 years
  2. Pregnant women or women with potential childbearing
  3. Life expectancy < 1 year
  4. Refusal or inability to understand of informed consent

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): NCT03947229


Locations
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Korea, Republic of
Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea Recruiting
Seoul, Korea, Republic of
Contact: Byeong-Keuk Kim, PhD    82-2-2228-8460    kimbk@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03947229     History of Changes
Other Study ID Numbers: 4-2019-0234
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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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 Yonsei University:
Patients who underwent percutaneous coronary intervention with DES implantation carrying high risks for the recurrent major adverse events.
anti platelet therapy
bleeding
Additional relevant MeSH terms:
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Myocardial Ischemia
Aspirin
Clopidogrel
Coronary Artery Disease
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
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
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents