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Myocardial InfarctionPhase 2NCT02492230

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

A Phase 2 study testing Left Atrial Appendage Closure Device (Watchman) and Warfarin in people with Myocardial Infarction, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Left Atrial Appendage Closure Device (Watchman) and Warfarin
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteRussia
Study dates
May 2015to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • age <18 or >80 years old
  • INR >3
  • recurrent myocardial infarction
  • myocardial infarction with ST elevation
  • EF<50%
  • severe comorbidities
Show all 14Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Alexander Romanov, MD, PhD contact

abromanov@mail.ru

Marina Nikitenko contact

m_nikitenko@meshalkin.ru

Russia1 site, 1 recruiting

  • State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

    Novosibirsk, 630055

    Evgeny Pokushalov, MD, PhD, +79139254858, E.Pokushalov@gmail.com

    Evgeny Pokushalov, MD, PhD

    Recruiting

Other trials in Russia

About this study

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

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.

Read the 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.

Being tested
Left Atrial Appendage Closure Device (Watchman), Warfarin
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left Atrial Appendage Closure Device (Watchman)Device

    Also called PCI

    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.

  • WarfarinDrug

    Also called PCI

    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.

Study groups in NCT02492230
Study groupRoleWhat they receive
Control GroupActive 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.
Receives: Drug: Warfarin
Study GroupExperimentalLeft 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
Receives: Device: Left Atrial Appendage Closure Device (Watchman)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with bleeding according TIMI and GUSTO scales

    Measured: 12 months

Secondary outcomes (10)

  1. Cardiovascular death

    Measured: 12 month

  2. Sudden cardiac death

    Measured: 12 month

  3. Death due to heart failure

    Measured: 12 month

  4. Death due to stroke

    Measured: 12 month

  5. Death due to cardiovascular procedures

    Measured: 12 month

  6. Death due to CV hemorrhage

    Measured: 12 month

  7. Death due to other CV causes

    Measured: 12 month

  8. Periprocedural complications on first FU visit

    Measured: 1,5 month

  9. All neurologic events with documented diagnosis of stroke or transient ischemic attack

    Measured: 12 month

  10. Definite stent thrombosis

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionMar 2016
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02492230
Sponsor's protocol ID
241592LLAPCI
Status last verified
Sep 2017
First submitted
30 Jun 2015
Last updated
8 Sep 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Left Atrial Appendage Closure Device (Watchman) and Warfarin in people with Myocardial Infarction, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alexander Romanov, MD, PhD (abromanov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with bleeding according TIMI and GUSTO scales (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02492230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.

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