Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent PCI
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 30, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 8, 2017
September 1, 2017
10 months
June 30, 2015
September 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with bleeding according TIMI and GUSTO scales
12 months
Secondary Outcomes (10)
Cardiovascular death
12 month
Sudden cardiac death
12 month
Death due to heart failure
12 month
Death due to stroke
12 month
Death due to cardiovascular procedures
12 month
- +5 more secondary outcomes
Study Arms (2)
Control Group
ACTIVE COMPARATORAfter 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.
Study Group
EXPERIMENTALLeft 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Novosibirsk, 630055, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Evgeny Pokushalov, MD, PhD
State Research Institute of Circulation Pathology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2015
First Posted
July 8, 2015
Study Start
May 1, 2015
Primary Completion
March 1, 2016
Study Completion
December 1, 2017
Last Updated
September 8, 2017
Record last verified: 2017-09