Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 72 of 292 for:    ASPIRIN AND clopidogrel AND dual

Safety and Efficacy of Left Atrial Appendage Closure Versus Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-Eluting Stent Implantation Due to Complex Coronary Artery Disease

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02606552
Recruitment Status : Terminated (The number of patients registered for the study was low and it was expected to be difficult to derive the study results.)
First Posted : November 17, 2015
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

Comparatively analyze the safety and validity of Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure, and the medical treatment with dabigatran plus aspirin or dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy)) in patient with coronary artery disease treated with drug-eluting stent, accompanying atrial fibrillation.

Total of 670 patients [left atrial appendage occlusion registry with 100 ACP/ 570 anti-coagulation registry: (285 Dabigatran plus aspirin) and (285 Dabigatran plus clopidogrel) therapy)] will be comparatively analyzed the safety and efficacy. Primary endpoints were a composite of death, non-fatal myocardial infarction, stroke, systemic embolism, and GUSTO bleeding (moderate to severe).


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Coronary Artery Disease Drug: Dabigatrain plus aspirin Drug: Dabigatrain plus clopidogrel Device: Amplazter Cardiac Plug (ACP) Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 20, 2016
Actual Primary Completion Date : June 23, 2017
Actual Study Completion Date : June 23, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dabigatran plus aspirin
Medical treatment with dabigatran plus aspirin after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy))
Drug: Dabigatrain plus aspirin
Dabigatran (Pradaxa®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with atrial fibrillation. Aspirin is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop clopidogrel (maintain dabigatran + aspirin) at 3 months after PCI.

Experimental: Dabigatran plus clopidogrel
medical treatment with dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT)
Drug: Dabigatrain plus clopidogrel
Clopidogrel is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop aspirin (maintain dabigatran + clopidogrel) at 3 months after PCI.

Amplazter Cardiac Plug (ACP)
Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure
Device: Amplazter Cardiac Plug (ACP)
Patients allocated to the intervention group should be received percutaneous closure of the LAA by use of the ACP device (St. Jude Medical, St Paul, MN, USA).




Primary Outcome Measures :
  1. MACCE (Major adverse cardiac and cerebrovascular events) [ Time Frame: 5 years ]
  2. GUSTO bleeding [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Occurence of procedural related complications [ Time Frame: 5 years ]


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

Inclusion Criteria:

  1. Patients older than 20 years accompanying chronic atrial fibrillation with CHADS2 score ≥2
  2. Patients with coronary artery disease (which requires DES) should receive the 2nd generation drug-eluting stent insertion treatment
  3. Subjects and their legal representatives must understand the main purpose of this study, agree with relevant provisions, and sign to consent forms approved by IRBs of each institution.
  4. Subjects should agree with the follow-up studies as (coronary angiography) and transesophageal echocardiography, etc.
  5. Subjects should agree to follow our requests for post-operative follow-up visits.

Exclusion Criteria:

  1. Patients showing any hypersensitive reaction or reason for restriction to aspirin, heparin, clopidogrel, or warfarin, or otherwise, susceptible to contrast media, and therefore, who could not use those drugs and who were pregnant or breast feeding.
  2. Comorbidities other than atrial fibrillation that required chronic warfarin use.
  3. Patients diagnosed with progressive infection condition or endocarditis.
  4. Patients who have been diagnosed with progressive gastric ulcer or upper gastrointestinal bleeding for last 3 months.
  5. Hemodynamically unstable patients who needs inotropic supports.
  6. Senile dementia patients who have experienced any cerebrovascular accident (CVA) for last 6 weeks.
  7. Patients who have been diagnosed with intracardiac mass, thrombus, or vegetation as echocardiographic findings.
  8. Patients diagnosed with severe left ventricular dysfunction (<LVEF 30%).
  9. Patients with blood disorder as followings: leucopenia (<WBC 3,000mm3), acute anemia (<Hg 9mg %), Thrombocytopenia (<100,000 platelets/mm3), or any evidence of bleeding or clotting disorders.
  10. Patients showing life expectancy less than 12 months because of noncardiac comorbidities.
  11. Patients having severe vein occlusion at femoral vein, ceiling vein, or inferior vena cava.
  12. A patent foramen ovale with atrial septal aneurysm and right-to-left shunt
  13. Symptomatic carotid artery disease
  14. Patients with severe valvular heart disease
  15. Patients who are currently participating in other clinical trials for any drug or medical device.

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): NCT02606552


Locations
Layout table for location information
Korea, Republic of
Division of Cardiology, Severance Cardiovascular Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02606552     History of Changes
Other Study ID Numbers: 1-2014-0074
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

Keywords provided by Yonsei University:
drug eluting stent
atrial appendage closure

Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Clopidogrel
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dabigatran
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