Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 292 for:    ASPIRIN AND clopidogrel AND dual

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

Layout table for study information
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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location contacts
Contact: Duk-woo Park, MD dwpark@amc.seoul.kr
Contact: Jung-hwa Lee, RN 82230104734 nurse9726@amc.seoul.kr

Locations
Layout table for location information
Korea, Republic of
Hallym University Sacred Heart Hospital Not yet recruiting
Anyang, Korea, Republic of
Contact: Kyoung-ha Park, MD       pkhmd@naver.com   
Principal Investigator: Kyoung-ha Park, MD         
Soon Chun Hyang University Hospital Bucheon Not yet recruiting
Bucheon, Korea, Republic of
Contact: Jon Suh, MD       immanuel@schmc.ac.kr   
Principal Investigator: Jon Suh, MD         
Soonchunhyang University Hospital, Cheonan Not yet recruiting
Cheonan, Korea, Republic of
Contact: Se-whan Lee, MD       lovelee93@hanmail.net   
Principal Investigator: Se-whan Lee, MD         
Chungbuk National University Hospital Not yet recruiting
Cheongju-si, Korea, Republic of
Contact: Jang-whan Bae, MD       drcorazon@hanmail.net   
Principal Investigator: Jang-whan Bae, MD         
Gangwon National Univ. Hospital Not yet recruiting
Chuncheon, Korea, Republic of
Contact: Bong-ki Lee, MD       mdbklee@kangwon.ac.kr   
Principal Investigator: Bong-ki Lee, MD         
Daegu Catholic University Medical Center Not yet recruiting
Daegu, Korea, Republic of
Contact: Jin-bae Lee, MD       jblee@cu.ac.kr   
Principal Investigator: Jin-bae Lee, MD         
Yeungnam University Medical Center Not yet recruiting
Daegu, Korea, Republic of
Contact: Woong Kim, MD       woongwa@yu.ac.kr   
Principal Investigator: Woong Kim, MD         
The Catholic University of Korea, Daejeon ST. Mary's Hospital Not yet recruiting
Daejeon, Korea, Republic of
Contact: Sung-ho Her, MD       hhhsungho@naver.com   
Principal Investigator: Sung-ho Her, MD         
Chonnam National University Hospital Not yet recruiting
Gwangju, Korea, Republic of
Contact: Young-keun Ahn, MD       cecilyk@chonnam.ac.kr   
Principal Investigator: Young-keun Ahn, MD         
Gachon University Gil Hospital Not yet recruiting
Incheon, Korea, Republic of
Contact: Tae-hoon Ahn, MD       encore@gilhospital.com   
Principal Investigator: Tae-hoon Ahn, MD         
Chonbuk National University Hospital Not yet recruiting
Jeonju, Korea, Republic of
Contact: Jei-keon Chae, MD       jkchae@chonbuk.ac.kr   
Principal Investigator: Jei-keon Chae, MD         
Dong-A Medical Center Not yet recruiting
Pusan, Korea, Republic of
Contact: Moo-hyun Kim, MD       kmh60@damc.or.kr   
Principal Investigator: Moo-hyun Kim, MD         
Inje University Pusan Paik Hospital Not yet recruiting
Pusan, Korea, Republic of
Contact: Jae-sik Jang, MD       jsjang@medimail.co.kr   
Principal Investigator: Jae-sik Jang, MD         
Seoul university Bundang hospital Not yet recruiting
Seongnam-si, Korea, Republic of
Contact: Jung-won Suh, MD       suhjw1@gmail.com   
Principal Investigator: Jung-won Suh, MD         
Bundang CHA Hospital Not yet recruiting
Seongnam, Korea, Republic of
Contact: Won-jang Kim, MD       mdwjkim@gmail.com   
Principal Investigator: Won-jang Kim, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Duk-woo Park, MD       dwpark@amc.seoul.kr   
Principal Investigator: Duk-woo Park, MD         
Eulji Medical Center, Eulji University Not yet recruiting
Seoul, Korea, Republic of
Contact: Jae-woong Choi, MD       cjw1108@eulji.ac.kr   
Principal Investigator: Jae-woong Choi, MD         
Korea University Guro Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Won-young Jang, MD       raph83@naver.com   
Principal Investigator: Won-young Jang, MD         
The Catholic Univ. of Korea Seoul St. Mary's hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Yoon-seok Koh, MD       kyoonseok@catholic.ac.kr   
Principal Investigator: Yoon-seok Koh, MD         
The Catholic University of Korea, Yeouido St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Chul-soo Park, MD       charlie@catholic.ac.kr   
Principal Investigator: Chul-soo Park, MD         
St.Carollo Hospital Not yet recruiting
Suncheon, Korea, Republic of
Contact: Jang-hyun Cho, MD       goodnew8@naver.com   
Principal Investigator: Jang-hyun Cho, MD         
Wonju Severance Christian Hospital Not yet recruiting
Wonju, Korea, Republic of
Contact: Jung-han Yoon, MD       jyoon@yonsei.ac.kr   
Principal Investigator: Jung-han Yoon, MD         
Sponsors and Collaborators
Duk-Woo Park, MD
CardioVascular Research Foundation, Korea

Layout table for additonal information
Responsible Party: Duk-Woo Park, MD, Professor, Division of Cardiology, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03465644     History of Changes
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

Layout table for additional information
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:
Layout table for MeSH terms
Aspirin
Clopidogrel
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular 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