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TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI (TAILORED-CHIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03465644
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Duk-Woo Park, MD, Asan Medical Center

Brief Summary:
This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex PCI as compared with standard Dual Antiplatelet Therapy(aspirin and clopidogrel for 12 months).

Condition or disease Intervention/treatment Phase
Coronary Stenoses Drug: Tailored antithrombotic strategy Drug: Conventional antithrombotic strategy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Tailored Antiplatelet Therapy With Early Escalation and Late De-Escalation Strategy Versus Standard Dual Antiplatelet Therapy in Patients Undergoing Complex High-Risk Percutaneous Coronary Intervention
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Tailored arm
early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy
Drug: Tailored antithrombotic strategy
Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months

Active Comparator: Conventional arm
clopidogrel + aspirin for 12months
Drug: Conventional antithrombotic strategy
Clopidogrel + aspirin for 12months




Primary Outcome Measures :
  1. Net clinical outcome [ Time Frame: 1 year ]
    a net clinical outcome of all-cause death, MI, stroke, stent thrombosis, urgent revascularization and clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5] at 12 months post-PCI.


Secondary Outcome Measures :
  1. All-cause death [ Time Frame: 1 year ]
  2. Myocardial infarction [ Time Frame: 1 year ]
  3. Stroke [ Time Frame: 1 year ]
  4. Stent thrombosis [ Time Frame: 1 year ]
  5. Urgent revascularization [ Time Frame: 1 year ]
  6. Clinically relevant bleeding [ Time Frame: 1 year ]
    Bleeding Academic Research Consortium (BARC) 2, 3, or 5

  7. Composite of death (all or cardiovascular), MI, or stroke, stent thrombosis or urgent revascularization [ Time Frame: 1 year ]
  8. Composite of death (all or cardiovascular), MI, or stroke [ Time Frame: 1 year ]
  9. Composite of death (all or cardiovascular) or MI [ Time Frame: 1 year ]
  10. Any revascularization [ Time Frame: 1 year ]
  11. BARC type 3 or 5 bleeding [ Time Frame: 1 year ]
  12. Major or minor bleeding according to definitions from The Thrombolysis in Myocardial Infarction (TIMI) [ Time Frame: 1 year ]
  13. Major or minor bleeding according to definitions from International Society of Thrombosis or Hemostasis (ISTH) [ Time Frame: 1 year ]


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

Inclusion Criteria:

  • Age 19 and more
  • Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
  • at least one of the following high-risk clinical, lesion or procedure-related risk factors;
  • Clinical factors: diabetes, chronic kidney disease (i.e. creatinine clearance <60 mL/min), or low left ventricular ejection fraction (<40%) or
  • Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two-stent technique, severe calcification, diffuse long lesion (lesion length ≥ at least 30 mm), multi-vessel PCI (≥ 2 vessels requiring stent implantation), ≥3 requiring stent implantation, ≥ 3 lesions will be treated, or predicted total stent length for revascularization > 60 mm

Exclusion Criteria:

  • Enzyme-positive ACS (NSTEMI or STEMI)
  • Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
  • Cardiogenic shock at the index admission
  • Treated with only bare metal stent or balloon angioplasty during the index procedure
  • Need for chronic oral anticoagulation
  • Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)
  • History of intracranial haemorrhage or intracranial aneurysm
  • Planned surgery within 180 days
  • Liver cirrhosis
  • Dialysis-dependent renal failure
  • Pregnant and/or lactating women
  • Concurrent medical condition with a life expectancy of less than 1 years
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
  • Unable to provide written informed consent or participate in long-term follow-up

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): NCT03465644


Contacts
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Contact: Duk-woo Park, MD dwpark@amc.seoul.kr
Contact: Jung-hwa Lee, RN 82230104734 nurse9726@amc.seoul.kr

Locations
Show Show 22 study locations
Sponsors and Collaborators
Duk-Woo Park, MD
CardioVascular Research Foundation, Korea

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Responsible Party: Duk-Woo Park, MD, Professor, Division of Cardiology, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03465644    
Other Study ID Numbers: AMCCV2018-03
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Duk-Woo Park, MD, Asan Medical Center:
antithrombotic strategy
dual antiplatelet therapy
Additional relevant MeSH terms:
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Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Clopidogrel
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