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Optimal Antithrombotic Therapy for ACS Patients Concomitant AF Undergoing New Generation DES Implantation

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ClinicalTrials.gov Identifier: NCT03234114
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:

It is a prospective, multi-centered, randomized clinical trial (RCT) which will enroll 1550 patients with acute coronary syndrome (ACS) concomitant non-valvular atrial fibrillation (NVAF) and undergoing new generation drug eluting stent (DES) implantation at approximately 60 centers nationwide in China and contains two sub-studies.

In the OPTIMAL-1 sub-study, 600 subjects who choose warfarin as anticoagulant will randomly receive triple antithrombotic therapy (warfarin with targeted INR 2.0-2.5, clopidogrel 75 mg od and aspirin 100 mg od) for 1 month or 6 months in a 1:1 ratio then quit aspirin till 12 months after percutaneous coronary intervention (PCI). The primary endpoint of the OPTIMAL-1 is a composite efficacy outcome of death (cardiac death or sudden death), thrombotic events (nonfatal myocardial infarction, ischemic stroke or systemic thromboembolism) and unplanned revascularization up to 12 months; the major secondary endpoint is major bleeding or clinically relevant non-major bleeding (CRNMB) according to the International Society of Thrombosis and Hemostasis (ISTH) definition.

In the OPTIMAL-2 sub-study, 950 subjects who prefer dabigatran will be randomly assigned in a 1:1 ratio to a dual antithrombotic therapy of dabigatran 110 mg twice daily with ticagrelor 90 mg twice daily or with clopidogrel 75 mg od for 12 months after PCI. The primary endpoint of the OPTIMAL-2 is major bleeding or CRNMB assessed by the ISTH definition at 12 months; the major secondary endpoints comprise a composite efficacy outcome of death (cardiac death or sudden death), thrombotic events (nonfatal myocardial infarction, ischemic stroke or systemic thromboembolism) and unplanned revascularization (ARC criteria), stroke (ischemic and hemorrhagic), systemic thromboembolism, bleeding (ISTH and BARC criteria) and net clinical benefit.

Other secondary endpoints comprise death (all-cause death, cardiac death or sudden death), myocardial infarction (all and nonfatal), unplanned revascularization (target or non-target vessel, target or non-target lesion), stent thrombosis (ARC criteria), stroke (ischemic and hemorrhagic), systemic thromboembolism, bleeding (ISTH and BARC criteria) and net clinical benefit.

All endpoints will be collected and compared between subgroups and sub-studies during hospitalization and in 1 month (± 7 days), 6 months (± 7 days) and 12 months (± 7 days) for office visits and in 2 weeks (± 7 days), 2 months (± 7 days) and 3 months (± 7 days) for phone call visits.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome (ACS) Non-valvular Atrial Fibrillation (NVAF) Drug: Triple antithrombotic therapy Drug: Dual antithrombotc therapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Antithrombotic Therapy for Acute Coronary Syndrome Patients Concomitant Atrial Fibrillation Undergoing New Generation Drug Eluting Stent Implantation
Actual Study Start Date : February 3, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1-month TT
Randomized control group in the OPTIMAL-1 substudy; Triple antithrombotic therapy (warfarin with targeted INR 2.0-2.5, clopidogrel 75 mg od and aspirin 100 mg od) for 1 month (30 days) then quit aspirin till 12 months after PCI
Drug: Triple antithrombotic therapy
Including warfarin with targeted INR 2.0-2.5 (Shanghai Xinyi pharma co., LTD, China), aspirin 100 mg per day (Bayer, Germany) and clopidogrel 75 mg per day (Sanofi, France)
Other Name: TT

Experimental: 6-month TT
Randomized control group in the OPTIMAL-1 substudy; Triple antithrombotic therapy (warfarin with targeted INR 2.0-2.5, clopidogrel 75 mg od and aspirin 100 mg od) for 6 months (180 days)then quit aspirin till 12 months after PCI
Drug: Triple antithrombotic therapy
Including warfarin with targeted INR 2.0-2.5 (Shanghai Xinyi pharma co., LTD, China), aspirin 100 mg per day (Bayer, Germany) and clopidogrel 75 mg per day (Sanofi, France)
Other Name: TT

Experimental: 12-month DT-1
Randomized control group in the OPTIMAL-2 substudy; Dual antithrombotic therapy including dabigatran 110 mg b.i.d. with clopidogrel 75 mg qd for 12 months after PCI
Drug: Dual antithrombotc therapy
Including dabigatran 110 mg b.i.d. (Boehringer Ingelheim, Germany) plus ticagrelor 90 mg b.i.d. (AstraZeneca, Britain) or clopidogrel 75 mg per day (Sanofi, France)
Other Name: DT

Experimental: 12-month DT-2
Randomized control group in the OPTIMAL-2 substudy; Dual antithrombotic therapy including dabigatran 110 mg b.i.d. with ticagrelor 90 mg b.i.d for 12 months after PCI
Drug: Dual antithrombotc therapy
Including dabigatran 110 mg b.i.d. (Boehringer Ingelheim, Germany) plus ticagrelor 90 mg b.i.d. (AstraZeneca, Britain) or clopidogrel 75 mg per day (Sanofi, France)
Other Name: DT




Primary Outcome Measures :
  1. Primary endpoint of OPTIMAL-1 [ Time Frame: Up to 12 months (± 7 days) after inclusion ]
    A composite efficacy outcome of death (cardiac death or sudden death), thrombotic events (nonfatal myocardial infarction, ischemic stroke or systemic thromboembolism) and unplanned revascularization

  2. Primary endpoint of OPTIMAL-2 [ Time Frame: Up to 12 months (± 7 days) after inclusion ]
    Major bleeding or clinically relevant non-major bleeding assessed by the ISTH definition


Secondary Outcome Measures :
  1. Major secondary endpoint of OPTIMAL-1 [ Time Frame: Up to 12 months (± 7 days) after inclusion ]
    Major bleeding or clinically relevant non-major bleeding assessed by the ISTH definition

  2. Major secondary endpoint of OPTIMAL-2 [ Time Frame: Up to 12 months (± 7 days) after inclusion ]
    A composite efficacy outcome of death (cardiac death or sudden death), thrombotic events (nonfatal myocardial infarction, ischemic stroke or systemic thromboembolism) and unplanned revascularization

  3. Other secondary endpoints of OPTIMAL-1/2 [ Time Frame: Up to 12 months (± 7 days) after inclusion ]
    Death (all-cause death, cardiac death or sudden death), myocardial infarction (all and nonfatal), unplanned revascularization (target or non-target vessel, target or non-target lesion), stent thrombosis (ARC criteria), stroke (ischemic and hemorrhagic), systemic thromboembolism, bleeding (ISTH and BARC criteria) and net clinical benefit.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 year
  • ACS patients concomitant non-valvular AF underwent PCI and new-generation DES implantation
  • CHA2DS2-VASc score ≥ 2 and in need of OAC treatment
  • In a low to moderate risk of bleeding (HAS-BLED score < 3)
  • Volunteer to participate and sign informed consent
  • Approved by national regulatory authorities ethics committees at participating centers.

Exclusion Criteria:

  • Implantation of other types of stent during this PCI
  • DES implantation in the left main stem
  • Cardiogenic shock or Killip III-IV
  • STEMI patients with malignant arrhythmias or underwent electrodefibrillation or CPR or with cardiac mechanical complications (heart rupture, ventricular septal perforation, nipple muscle fracture, etc.)
  • History of severe gastrointestinal or intracranial hemorrhage; active bleeding, recent trauma or major surgery in the last month; suspected or diagnosed aortic dissection
  • Known allergy or intolerance to the study medications: warfarin, clopidogrel, aspirin, dabigatran, ticargrelor and heparin
  • Previous enrollment in other trials without achieving primary endpoint
  • Planned major surgery within the next 12m with the need to discontinue antiplatelet therapy
  • Planned RFCA or left atrial appendage occlusion within the next 12m
  • Abnormal liver or kidney function (ALT > 3 ULN; estimated CrCl < 30 ml/min calculated by Cockcroft-Gault equation); diagnosed liver cirrhosis
  • History of blood system disease or bleeding tendency; hemoglobin < 100 g/L, platelet count < 100 × 10^9 cells/L, or > 600 × 10^9 cells/L
  • Malignancies or other comorbid conditions with life expectancy less than 1 year
  • Pregnant (present, suspected, or planned) or lactating woman
  • Patients in need of drugs which affect the efficacy of clopidogrel such as miconazole, ketoconazole, fluconazole, voriconazole, itraconazole, posaconazole, efinaconazole, and rifampicin

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): NCT03234114


Contacts
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Contact: Chunjian Li, Dr, PhD +86-13701465229 drcjli@hotmail.com
Contact: Xiaoxuan Gong, MD +86-18851727059 xiaoxuangong@sina.com

Locations
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China, Jiangsu
First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Fuming Zhang, M.D.    +86-25-83718836 ext 6360    jsphkj@163.com   
Contact: Yi Chai, M.D.    +86-25-83718836 ext 6360    jsphkj@163.com   
Principal Investigator: Chunjian Li, Ph.D         
Sub-Investigator: Xiaoxuan Gong, MD         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Principal Investigator: Chunjian Li, Dr, PhD The First Affiliated Hospital with Nanjing Medical University

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Responsible Party: Chunjian Li, Dr., MD, Ph.D, Director of CCU Ward, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03234114     History of Changes
Other Study ID Numbers: 007
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Chunjian Li, The First Affiliated Hospital with Nanjing Medical University:
new generation drug eluting stent (DES)
antithrombotic therapy
randomized clinical trial (RCT)

Additional relevant MeSH terms:
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Myocardial Ischemia
Aspirin
Clopidogrel
Syndrome
Atrial Fibrillation
Acute Coronary Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Dabigatran
Warfarin
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