Clinical trial NCT02492230: Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent PCI
Official title: Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myocardial Infarction
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
Collaborators: name: Boston Scientific Corporation
First posted: 2015-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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)

Primary outcomes:
measure: Number of patients with bleeding according TIMI and GUSTO scales
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular death
timeFrame: 12 month
measure: Sudden cardiac death
timeFrame: 12 month
measure: Death due to heart failure
timeFrame: 12 month
measure: Death due to stroke
timeFrame: 12 month
measure: Death due to cardiovascular procedures
timeFrame: 12 month
measure: Death due to CV hemorrhage
timeFrame: 12 month
measure: Death due to other CV causes
timeFrame: 12 month
measure: Periprocedural complications on first FU visit
timeFrame: 1,5 month
measure: All neurologic events with documented diagnosis of stroke or transient ischemic attack
timeFrame: 12 month
measure: Definite stent thrombosis
timeFrame: 12 month
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny Pokushalov, MD, PhD
role: STUDY_DIRECTOR
References: