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

Myocardial Infarction Clinical Trial

Official title:

Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent Percutaneous Coronary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02492230
• Other study ID #: 241592LLAPCI
• Status: Recruiting
• Phase: Phase 2
• First received: June 30, 2015
• Last updated: September 6, 2017
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Alexander Romanov, MD, PhD
• Email: abromanov[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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.

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.

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation	Novosibirsk

Sponsors (2)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation	Boston Scientific Corporation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with bleeding according TIMI and GUSTO scales		12 months
Secondary	Cardiovascular death		12 month
Secondary	Sudden cardiac death		12 month
Secondary	Death due to heart failure		12 month
Secondary	Death due to stroke		12 month
Secondary	Death due to cardiovascular procedures		12 month
Secondary	Death due to CV hemorrhage		12 month
Secondary	Death due to other CV causes		12 month
Secondary	Periprocedural complications on first FU visit		1,5 month
Secondary	All neurologic events with documented diagnosis of stroke or transient ischemic attack		12 month
Secondary	Definite stent thrombosis		12 month