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Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent PCI

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ClinicalTrials.gov Identifier: NCT02492230
Recruitment Status : Recruiting
First Posted : July 8, 2015
Last Update Posted : September 8, 2017
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Brief Summary:
The objective of Left atrial appendage closure compared to standard antiplatelet therapy in patients with AF who underwent percutaneous coronary intervention (LLA-PCI) study is to evaluate the safety and efficacy of implantation of left atrial appendage closure compared to standard antiplatelet therapy for prevention of thromboembolic events and stent thrombosis in subjects with AF who underwent PCI.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Device: Left Atrial Appendage Closure Device (Watchman) Drug: Warfarin Phase 2

Detailed Description:
This will be prospective randomized (1:1) open label pilot study. Patients with unstable angina and non-ST-elevation ACS and history of AF will be included in this study. After PCI and DES implantation TEE will be performed for assessing LAA anatomy and size eligible for left atrial appendage closure device implantation. After screening all patients will be randomized in two groups. The first (control) group will receive standard antiplatelet and anticoagulation therapy according to the guidelines (2), the second group of patients will undergo left atrial appendage closure device implantation. After the PCI the first group will take Triple therapy (warfarin + clopidogrel+aspirin) during 45 days and after combination of warfarin+clopidogrel to 6 months after procedure and then only warfarin. The second group will take Triple therapy (warfarin+clopidogrel+aspirin) during 45 days following PCI and after control TEE, warfarin will be discontinued. Then patients from the second group will take DAPT combination (clopidogrel+aspirin) to 6 months after procedure and then only aspirin. Patients will be followed at 45 day, and every 3 months during 12 months of follow up (Figure 1). At each follow-up visits the data regarding clinical events and healthcare utilization will be collected.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent Percutaneous Coronary Intervention
Study Start Date : May 2015
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: Control Group
After successful PCI the control group will take Triple therapy (warfarin + clopidogrel+aspirin) during 45 days and after combination of warfarin+clopidogrel to 6 months after procedure and then only warfarin. Patients will be followed at 45 day, and every 3 months during 12 months of follow up.
Drug: Warfarin

Warfarin dose adjusted to maintain INR 2.0-3.0 for all period of study; Aspirin dose-75mg for 45 days after randomization; Clopidogrel dose-75mg for 6 months after procedure.

All drugs will be started before PCI procedure. Low molecular weight heparins will be used before procedure and will be stopped when INR reach 1.8-2.0.

Other Name: PCI

Experimental: Study Group
Left Atrial Appendage Closure Device will be implanted immediately after successful PCI procedure. It will be implanted via a trans-septal approach by use of a catheter based delivery system to seal the ostium of the LAA. The implantation will be guided by fluoroscopy and TEE to verify proper positioning and stability. The study group will take Triple therapy (warfarin+clopidogrel+aspirin) during 45 days following PCI and after control TEE, warfarin will be discontinued. Then patients from the study group will take DAPT combination (clopidogrel+aspirin) to 6 months after procedure and then only aspirin. Patients will be followed at 45 day, and every 3 months during 12 months of follow up
Device: Left Atrial Appendage Closure Device (Watchman)
This device is a self-expanding nickel titanium (nitinol) frame structure with fixation barbs and a permeable polyester fabric cover. The device ranges in diameter from 21 mm to 33 mm to accommodate varying LAA anatomy and size. It will be implanted via a trans-septal approach by use of a catheter based delivery system to seal the ostium of the LAA. The implantation will be guided by fluoroscopy and TEE to verify proper positioning and stability. The dose of warfarin will be adjusted to maintain INR 2.0 - 3.0 for 45 days. If TEE data shows no additional flow in LAA, warfarin will be discontinued: Aspirin dose: 75 mg for all period of study; Clopidogrel dose: 75 mg for 6 months after procedure.
Other Name: PCI




Primary Outcome Measures :
  1. Number of patients with bleeding according TIMI and GUSTO scales [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Cardiovascular death [ Time Frame: 12 month ]
  2. Sudden cardiac death [ Time Frame: 12 month ]
  3. Death due to heart failure [ Time Frame: 12 month ]
  4. Death due to stroke [ Time Frame: 12 month ]
  5. Death due to cardiovascular procedures [ Time Frame: 12 month ]
  6. Death due to CV hemorrhage [ Time Frame: 12 month ]
  7. Death due to other CV causes [ Time Frame: 12 month ]
  8. Periprocedural complications on first FU visit [ Time Frame: 1,5 month ]
  9. All neurologic events with documented diagnosis of stroke or transient ischemic attack [ Time Frame: 12 month ]
  10. Definite stent thrombosis [ Time Frame: 12 month ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • age > 18 years old
  • Acute coronary syndrome without ST elevation and unstable angina 2 weeks before enrolment
  • Successful PCI procedure with DES
  • History of atrial fibrillation (paroxysmal, persistent or permanent) with ECG documentation within previous 12 month
  • CHA2DS2-VASC ≥ 2
  • HAS-BLED ≥ 3
  • LAA eligible for left atrial appendage closure device implantation (TEE data)

Exclusion criteria:

  • age <18 or >80 years old
  • INR >3
  • recurrent myocardial infarction
  • myocardial infarction with ST elevation
  • EF<50%
  • severe comorbidities
  • Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.
  • anemia < 100 g/l
  • uncontrolled hypertension
  • thrombocytopenia
  • oncology
  • obesity, BMI>40
  • LAA thrombosis
  • Women of childbearing potential (unless post-menopausal or surgically sterile)

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): NCT02492230


Contacts
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Contact: Alexander Romanov, MD, PhD abromanov@mail.ru
Contact: Marina Nikitenko m_nikitenko@meshalkin.ru

Locations
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Russian Federation
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny Pokushalov, MD, PhD    +79139254858    E.Pokushalov@gmail.com   
Principal Investigator: Evgeny Pokushalov, MD, PhD         
Sub-Investigator: Alexander Romanov, MD, PhD         
Sub-Investigator: Denis Losik         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Boston Scientific Corporation
Investigators
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Study Director: Evgeny Pokushalov, MD, PhD State Research Institute of Circulation Pathology

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02492230     History of Changes
Other Study ID Numbers: 241592LLAPCI
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Ischemia
Infarction
Ischemia
Pathologic Processes
Necrosis
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
Purinergic Antagonists