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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 : Not yet recruiting
First Posted : July 31, 2017
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
It is a prospective, multi-centered, pragmatic clinical trial (PCT) which will enroll 800 acute coronary syndrome (ACS) patients concomitant non-valvular atrial fibrillation (NVAF) undergoing new generation drug eluting stent (DES) implantation in China. In the randomized control group, subjects will receive triple antithrombotic therapy (TT) including warfarin with targeted INR 2.0-2.5, clopidogrel 75 mg per day and aspirin 100 mg per day for 4 weeks or 6 months in a randomized way after percutaneous coronary intervention (PCI) with new generation DES. Then a dual antithrombotic therapy including warfarin (targeted INR 2.0-2.5) and clopidogrel 75 mg per day will be administrated till 12 months after PCI. In the cohort group, dabigatran 110 mg b.i.d plus ticargrelor 90 mg b.i.d or clopidogrel 75 mg q.d will be dosed for 12 months after PCI. The baseline characteristics of all patients and outcomes in 2 groups including primary composite endpoints of all-cause death, non-fatal myocardial infarction, unplanned revascularization, ischemic stroke, major bleeding (BARC criteria ≥ 3a), and secondary endpoints including death, myocardial infarction, unplanned revascularization, stent thrombosis, stroke and bleeding (BARC criteria 1-5) will be collected and compared during hospitalization and in 4 weeks (± 7 days), 6 months (± 7 days) and 12 months (± 7 days) after inclusion for office visits and in 2 weeks (± 7 days), 2 months (± 7 days) and 3 months (± 7 days) after inclusion 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 : 800 participants
Allocation: Non-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
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 4 weeks TT
Randomized control group; Triple antithrombotic therapy (warfarin with targeted INR 2.0-2.5, clopidogrel 75 mg per day and aspirin 100 mg per day) for 4 weeks then warfarin (targeted INR 2.0-2.5) plus clopidogrel 75 mg per day till 12 months after PCI
Drug: Triple Antithrombotic therapy
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 months TT
Randomized control group; Triple antithrombotic therapy (warfarin with targeted INR 2.0-2.5, clopidogrel 75 mg per day and aspirin 100 mg per day) for 6 months then warfarin (targeted INR 2.0-2.5) plus clopidogrel 75 mg per day till 12 months after PCI
Drug: Triple Antithrombotic therapy
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 months DT
A prospective cohort group; Dual antithrombotic therapy (dabigatran 110 mg b.i.d. plus ticargrelor 90 mg b.i.d.or clopidogrel 75 mg qd) for 12 months after PCI
Drug: Dual antithrombotc therapy
dabigatran 110 mg b.i.d. plus ticargrelor 90 mg b.i.d. or clopidogrel 75 mg per day
Other Name: DT




Primary Outcome Measures :
  1. primary composite endpoints of all-cause death, non-fatal myocardial infarction, unplanned revascularization, ischemic stroke, major bleeding (BARC criteria ≥ 3a) [ Time Frame: from baseline to 12 months (± 7 days) after inclusion ]
    including all-cause death, non-fatal myocardial infarction, unplanned revascularization, ischemic stroke, major bleeding (BARC criteria ≥ 3a)


Secondary Outcome Measures :
  1. secondary endpoints of death, myocardial infarction, unplanned revascularization, stent thrombosis, stroke and bleeding (BARC criteria 1-5) [ Time Frame: from baseline to 12 months (± 7 days) after inclusion ]
    death(all-cause and cardiogenic), myocardial infarction (all and non-fatal), unplanned revascularization [(non-)target lesion revascularization), (non-)target vessel revascularization], stent thrombosis (definite, probable, possible), stroke (ischemic and hemorrhagic) and bleeding (BARC criteria 1-5)



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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:

  • Previous stenting within recent 1 year
  • 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 cardiopulmonary resuscitation 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: aspirin, clopidogrel, dabigatran, warfarin, and heparin
  • Previous enrollment in other trials without achieving primary endpoint
  • Planned major surgery within the next 12 months with the need to discontinue antiplatelet therapy
  • Abnormal liver or kidney function (ALT > 3 ULN; diagnosed hepatitis or liver cirrhosis; CrCl < 30 ml/min)
  • 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

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 +86-25-68136018 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
Nanjing, Jiangsu, China, 210029
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: January 26, 2018
Last Verified: January 2018
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 Chunjian Li, The First Affiliated Hospital with Nanjing Medical University:
new generation drug eluting stent (DES)
triple antithrombotic therapy (TT)
pragmatic clinical trial (PCT)

Additional relevant MeSH terms:
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Myocardial Ischemia
Syndrome
Atrial Fibrillation
Acute Coronary Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Clopidogrel
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
Purinergic P2 Receptor Antagonists