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Trial record 78 of 292 for:    ASPIRIN AND clopidogrel AND dual

Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent

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ClinicalTrials.gov Identifier: NCT03447379
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Bumkee Hong, Gangnam Severance Hospital

Brief Summary:

"•Prospective, open label, randomized, multicenter study

  • Patients treated with a new generation of Everolimus-eluting stents (Synergy®). After PTCA, patients are randomized to a group of DAPT for one year or a group of P2Y12 monotherapy after 3 months of DAPT. After 12 months of PTCA, evaluate major cardiovascular events and major bleeding events
  • This study is to confirm after PTCA, DAPT for three months is not considered to be inferior to keeping DAPT for a year.

Condition or disease Intervention/treatment Phase
Coronary Artery Occlusive Disease Drug: 1. P2Y12 inhibitor monotherapy after 3 months of DAPT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Active Comparator: P2Y12 monotherapy after 3 months of DAPT
P2Y12 inhibitor(Clopidogrel 75mg/day or Ticagrelor 180mg/day) for 9months after 3 months of DAPT(Aspirin 100mg + Clopidogrel 75mg/day or Aspirin 100mg + Ticagrelor 180mg/day)
Drug: 1. P2Y12 inhibitor monotherapy after 3 months of DAPT
  1. P2Y12 inhibitor(Clopidogrel 75mg/day or Ticagrelor 180mg/day) for 9months after 3 months of DAPT(Aspirin 100mg + Clopidogrel 75mg/day or Aspirin 100mg + Ticagrelor 180mg/day)
  2. DAPT(Aspirin 100mg + Clopidogrel 75mg/day or Aspirin 100mg + Ticagrelor 180mg/day) for a year

Active Comparator: Dual-antiplatelet therapy for a year
DAPT(Aspirin 100mg + Clopidogrel 75mg/day or Aspirin 100mg + Ticagrelor 180mg/day) for a year
Drug: 1. P2Y12 inhibitor monotherapy after 3 months of DAPT
  1. P2Y12 inhibitor(Clopidogrel 75mg/day or Ticagrelor 180mg/day) for 9months after 3 months of DAPT(Aspirin 100mg + Clopidogrel 75mg/day or Aspirin 100mg + Ticagrelor 180mg/day)
  2. DAPT(Aspirin 100mg + Clopidogrel 75mg/day or Aspirin 100mg + Ticagrelor 180mg/day) for a year




Primary Outcome Measures :
  1. Major adverse cardiovascular clinical events (MACCE) [ Time Frame: between 3 and 12 month after the procedure ]
    cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization

  2. Major bleeding [ Time Frame: between 3 and 12 month after the procedure ]
    The Bleeding Academic Research Consortium (BARC) type 3 or 5



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 19+
  2. Patients treated with a new generation of Evelorimus-eluting stents (Synergy®)
  3. Patients who understand the content of the subject description and voluntarily sign the subject

Exclusion Criteria:

  1. Age 86+
  2. Hemodynamically unstable patient
  3. Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent
  4. Patients at high risk of bleeding, anemia, thrombocytopenia
  5. Patients requiring oral anticoagulants
  6. Pregnant women or women of childbearing age
  7. Life expectancy is less than one year
  8. Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir)
  9. Patients with a history of intracranial hemorrhage
  10. Patients with moderate to severe hepatic impairment
  11. Patients underwent coronary intervention with stenting within 1 year
  12. Patients with left-main lesions requiring coronary intervention
  13. Patients with chronic stricture lesions requiring treatment
  14. Patients with in-stent restenosis in a lesion requiring treatment
  15. Patients with bifurcation lesions requiring stenting in lateral branches
  16. Patients with lesions requiring more than 3 stents

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): NCT03447379


Contacts
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Contact: Bumkee Hong, MD 82-2-2019-3311 bkhong@yuhs.ac
Contact: Bumkee Hong 82-2-2019-3311 bkhong@yuhs.ac

Locations
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Korea, Republic of
Gangnam Severance Hospital Recruiting
Seoul, Souel, Korea, Republic of
Contact: BumKee Hong, MD    82-2-2019-3311      
Sponsors and Collaborators
Gangnam Severance Hospital
Investigators
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Principal Investigator: Bumkee Hong Gangnam Severance Hospital

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Responsible Party: Bumkee Hong, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT03447379     History of Changes
Other Study ID Numbers: 3-2017-0230
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

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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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Aspirin
Clopidogrel
Everolimus
Ticagrelor
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
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents