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出境医 / 临床实验 / 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

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

Study Description
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.
Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
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
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE August 14, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019) 		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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • Each component of net adverse clinical events [ Time Frame: 24 months ]
  • All-cause or cardiovascular mortality [ Time Frame: 24 months ]
  • Major or minor bleeding [ Time Frame: 24 months ]
    Major or minor bleeding would be defined by BARC and TIMI criteria
  • Major adverse cardiac event [ Time Frame: 24 months ]
    Major Adverse Cardiac events includes all-cause of death, myocardial infarctions, stent thrombosis, or stroke.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Coronary Artery Disease
  • DES
Intervention  ICMJE
  • Drug: Clopidogrel mono-therapy
    Patients will receive clopidogrel (75 mg once daily) monotherapy without co-administration of aspirin for 24 months after randomization.
  • Drug: Dual-antiplatelet therapy
    Patients will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 24 months after randomization.
Study Arms  ICMJE
  • Active Comparator: Clopidogrel mono-therapy
    After randomization, patients will receive clopidogrel monotherapy after DES implantation for 24 months.
    Intervention: Drug: Clopidogrel mono-therapy
  • Active Comparator: Dual-antiplatelet therapy
    Patients will receive dual antiplatelet consisting of aspirin and clopidogrel.
    Intervention: Drug: Dual-antiplatelet therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019) 		3200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03947229
Other Study ID Numbers  ICMJE 4-2019-0234
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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