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Trial record 37 of 402 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Monotherapy (HOST-EXAM)

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ClinicalTrials.gov Identifier: NCT02044250
Recruitment Status : Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : July 19, 2019
Sponsor:
Collaborators:
Chong Kun Dang Pharmaceutical
Samjin Pharmaceutical Co., Ltd.
Daewoong Pharmaceutical Co. LTD.
Hanmi Pharmaceutical co., ltd.
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital

Brief Summary:

Objectives :

To compare the efficacy and safety of clopidogrel monotherapy with aspirin monotherapy in patients who received dual or triple antiplatelet therapy for 1 year (± 6 months) after drug-eluting stent implantation for coronary artery disease

Patient Enrollment :

5530 patients enrolled at 55 centers in Korea

Patient Follow-up :

Clinical follow-up will occur at 1, 12 and 24 months.

Primary Endpoint :

Composite endpoint of MACE and major bleeding

Secondary Endpoint :

Device-oriented composite outcome including TLR (target lesion revascularization), TVR (target vessel revascularization), stent thrombosis, and minor GI (gastrointestinal) complications


Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Clopidogrel Drug: Aspirin Phase 4

Detailed Description:

The primary purpose of this study is to compare the efficacy and safety of antiplatelet monotherapy with aspirin or clopidogrel for 2 years in patients who have not experienced MACE (major adverse cardiac events) including all-cause death, acute coronary syndrome including non-fatal MI (myocardial infarction), or urgent revascularization under combined antiplatelet therapy for 12 ± 6 months after PCI (percutaneous coronary intervention) with DES (drug-eluting stents). The trial tests the hypothesis that clopidogrel is superior to aspirin in preventing clinical events and device-oriented outcomes. Clinical events are defined as a composite of all-cause death, non-fatal MI, stroke, readmission due to acute coronary syndrome (ACS), or Bleeding Academic Research Consortium (BARC) class ≥ 3.29 Device-oriented outcomes include target lesion/vessel revascularization (TLR/TVR) and Academic Research Consortium (ARC)-defined stent thrombosis.

The primary endpoint of this study is the rate of clinical events defined as a composite of MACE and major bleeding complications. MACE includes all-cause death, non-fatal MI, stroke, and readmission due to ACS (acute coronary syndrome). Major bleeding is defined as bleeding (BARC class ≥ 3) at 24 months. Non-fatal MI is defined as any confirmed evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia without resulting in death, which is supported by electrocardiography, cardiac enzymes, or cardiac imaging according to the third Universal Definition of MI.37, 38 A readmission due to ACS is defined as any re-hospitalization definitely originating from an ACS event, which satisfies the definition of the American College of Cardiology Foundation and the American Heart Association.37, 39 A stroke is defined as any abrupt-onset, non-convulsive, focal, or global neurological deficit lasting more than 24 hours, which is caused by ischemia or hemorrhage in the brain.39 Secondary endpoints are the rate of device-oriented outcomes including TLR/TVR and stent thrombosis at 24 months, and minor gastrointestinal (GI) complications with the related cost-effectiveness. TLR is defined as any repeat revascularization procedure at the original lesion of the index procedure any time during the follow-up period.40 TVR is defined as any repeat revascularization procedure involving at least one of the target vessels that were treated in the index procedure.40 Stent thrombosis is defined according to the ARC.41, 42 Minor GI complications are assessed on the basis of newly developed GI symptoms, newly added GI medications, or symptom-driven GI endoscopy. At each visit, clinicians will question the patient regarding GI symptoms from intermittent epigastric soreness or bloating due to melena/hematochezia. Any additional GI medications, including H2-blockers and proton pump inhibitors, will be documented for each patient. If a patient undergoes endoscopy, the type of endoscopy, test results, and further interventions will be recorded. Additional medical costs related to these minor GI complications (South Korean won/year) will be calculated to assess the cost effectiveness of each drug based on average Korean expenses. All endpoints will be assessed primarily by the investigator and adjudicated secondarily by the independent clinical event committee.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Clopidogrel vs. Aspirin Monotherapy Beyond Two Year After Drug-eluting Stent Implantation
Actual Study Start Date : February 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clopidogrel
Antiplatelet monotherapy : Clopidogrel 75mg P.O. daily
Drug: Clopidogrel
Clopidogrel 75mg 1tab P.O. daily
Other Name: Copregrel, Plateless, Cloart, Pidogul

Placebo Comparator: Aspirin
Antiplatelet monotherapy : Aspirin 100~200mg P.O. daily
Drug: Aspirin
Aspirin 100~200mg 1~2tab P.O. daily




Primary Outcome Measures :
  1. Composite of major adverse cardiovascular events (MACE) and major bleeding complications [ Time Frame: 2 years ]
    MACE, composite of all-cause death, non-fatal MI, stroke, and readmission due to ACS; major bleeding, bleeding of BARC class ≥3


Secondary Outcome Measures :
  1. Target vessel revascularization (TVR), target lesion revascularization (TLR) [ Time Frame: 2 years ]
    TVR, any repeat revascularization procedure involving at least one of the target vessels that were treated in the index procedure; TLR, any repeat revascularization procedure at the original lesion of the index procedure

  2. Stent thrombosis (acute, sub-acute, late, very late) [ Time Frame: 2 years ]
    defined according to the ARC

  3. Minor gastrointestinal (GI) complications [ Time Frame: 2 years ]
    newly developed GI symptoms, newly added GI medications, or symptom-driven GI endoscopy



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female aged ≥20 years
  2. Maintenance of dual or triple antiplatelet therapy at least 12 ± 6 months after PCI with DES
  3. No history of further clinical event after PCI with DES
  4. Plan to change to antiplatelet monotherapy
  5. Agreement to give written informed consent

Exclusion Criteria:

  1. History of hypersensitivity to aspirin or clopidogrel
  2. History of contraindication to aspirin or clopidogrel
  3. Active pathologic bleeding, such as peptic ulcer, tumor bleeding or intracranial hemorrhage
  4. History of major bleeding, BARC class ≥3, resulting in stop of antiplatelet agents within 3 months
  5. Bleeding diathesis
  6. Known coagulopathy or refusal of blood transfusion
  7. Presence of non-cardiac comorbidity with life expectancy <2 years from randomization
  8. Plan to surgery or intervention which needs to stop antiplatelet agents ≥3 months
  9. Females with childbearing potential or breast-feeding
  10. Conditions that may result in protocol non-compliance by the committees
  11. Co-administration of contraindicated medications as follows: other P2Y 12 inhibitors (prasugrel or ticagrelor); anticoagulants (warfarin, new oral anticoagulants, or chronic therapy of heparin); cytochrome P450 2C19 inhibitors (fluoxetine, moclobemid or voriconazole); probenecid; high dose of methotrexate (≥15 mg/week); lithium
  12. Refusal to give written 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): NCT02044250


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Chong Kun Dang Pharmaceutical
Samjin Pharmaceutical Co., Ltd.
Daewoong Pharmaceutical Co. LTD.
Hanmi Pharmaceutical co., ltd.
Investigators
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Study Chair: Hyo-Soo Kim, MD, PhD Seoul National University Hospital

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Responsible Party: Hyo-Soo Kim, Principal investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02044250     History of Changes
Other Study ID Numbers: HOST-EXAM Trial
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

Keywords provided by Hyo-Soo Kim, Seoul National University Hospital:
Aspirin
Clopidogrel
Antiplatelet monotherapy
Drug-eluting stent

Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive 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
Neurotransmitter Agents