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Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation (ASPIRIN-LAAO)

2021년 10월 9일 업데이트: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin after left atrial appendage occlusion (LAAO).

Patients diagnosed with atrial fibrillation and have undergone LAAO will be enrolled in this study. Randomization will be performed at 6 months post-implant. The randomization program electronically assigns the patient 1:1 to either the Aspirin group or the control group. Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day). The control group receives placebo. After the randomization, subjects of both groups will have follow-up visits at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment. For each group, 560 patients will be included, with an estimated total number of 1120 participants in this clinical study. Patients will be followed up until 24 months after the last enrollment.

The primary endpoint is a composite consisting of stroke, systemic embolism, cardiovascular or unexplainable death, acute coronary syndrome, coronary artery disease or periphery vascular disease requiring revascularization and major bleeding. The secondary endpoints are all-cause death, device related thrombus, minor bleeding and rehospitalization due to heart failure.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin since the sixth month after LAAO.

Patients diagnosed with paroxysmal or persistent atrial fibrillation with an age between 18 and 90 years and have undergone LAAO will be enrolled in this study. Randomization will be performed at 6 months post-implant. The randomization program electronically assigns the patient 1:1 to either the Aspirin group or the control group. Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day). The control group receives placebo. After the randomization, subjects of both groups will have follow-up visits at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment. For each group, 560 patients will be included, with an estimated total number of 1120 participants in this clinical study. Patients will be followed up until 24 months after the last enrollment.

The primary endpoint is a composite consisting of stroke, systemic embolism, cardiovascular or unexplainable death, acute coronary syndrome, coronary artery disease or periphery vascular disease requiring revascularization and major bleeding. The secondary endpoints are all-cause death, device related thrombus, minor bleeding and rehospitalization due to heart failure.

연구 유형

중재적

등록 (예상)

1120

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Shanghai
      • Shanghai, Shanghai, 중국, 200092
        • 모병
        • Xinhua Hospital, School of Medicne, Shanghai Jiao Tong University
        • 연락하다:
        • 수석 연구원:
          • Yi-Gang Li, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Age between 18 and 90 years
  • Paroxysmal, persistent, long-standing persistent or permanent nonvalvular AF
  • Have already had a Watchman LAAO device implanted 6 months ago

Exclusion Criteria:

Clinical Exclusion Criteria

  • Long-term aspirin therapy required
  • Including coronary artery disease, symptomatic carotid disease, prior myocardial infarction, strokes or systemic embolism, etc
  • Contraindicated for aspirin therapy
  • Including active peptic ulcer, thrombocytopenia or anemia, etc.
  • Uncontrolled malignant tumor
  • Abnormal liver, renal or coagulation function
  • Pregnant or pregnancy is planned during the course of the investigation
  • Terminal illness with life expectancy <1 year
  • Enrolled in another IDE or IND investigation of a cardiovascular device or an investigational drug

TEE Exclusion Criteria*

  • Peri-device leak >5mm
  • Device-related thrombus
  • Other intracardiac thrombus

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Aspirin group
Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day).
의약품: Aspirin Tablet
Aspirin 100mg qd
위약 비교기: Control group
Study patients assigned to control group will receive placebo.
의약품: Placebo
Placebo qd

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants with stroke
기간: 24 months after the date of randomization.
A stroke is a medical condition in which poor blood flow to the brain results in cell death. There are two main types of stroke: ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding. They result in part of the brain not functioning properly. Signs and symptoms of a stroke may include an inability to move or feel on one side of the body, problems understanding or speaking, dizziness, or loss of vision to one side. If symptoms last less than one or two hours it is known as a transient ischemic attack (TIA) or mini-stroke. A hemorrhagic stroke may also be associated with a severe headache. The symptoms of a stroke can be permanent. Brain computed tomography or MRI may help diagnose stroke.
24 months after the date of randomization.
Number of participants with systemic embolism
기간: 24 months after the date of randomization.

An embolism is the lodging of an embolus, a blockage-causing piece of material, inside a blood vessel. The embolus is usually a blood clot (thrombus). An embolism can cause partial or total blockage of blood flow in the affected vessel.

An embolism in which the embolus is a piece of thrombus is called a thromboembolism.

An embolism is usually a pathological event, i.e., accompanying illness or injury. Sometimes it is created intentionally for a therapeutic reason, such as to stop bleeding or to kill a cancerous tumor by stopping its blood supply.

Embolism can be classified as to where it enters the circulation either in arteries or in veins. Arterial embolism are those that follow and, if not dissolved on the way, lodge in a more distal part of the systemic circulation.
24 months after the date of randomization.
Number of participants with cardiovascular/unexplained death
기간: 24 months after the date of randomization.
Cardiovascular deaths refer to deaths due to heart dysfunction, injury of cardiac structure, coronary artery diseases and lethal arrhythmias or sudden death that cannot be explain. Cardiovascular deaths can be diagnosed with clinical symptoms or from the results of diagnostic examinations.
24 months after the date of randomization.
Number of participants with major bleedings
기간: 24 months after the date of randomization.
Major bleedings refer to the heavy bleedings of the mains organs of the body, usually include intracranial bleeding and gastrointestinal bleeding et al.. Brain computed tomography and gastrointestinal endoscope are the common approaches for diagnosing major bleedings.
24 months after the date of randomization.
Number of participants with acute coronary syndrome
기간: 24 months after the date of randomization.

Acute coronary syndrome is a syndrome (set of signs and symptoms) due to decreased blood flow in the coronary arteries such that part of the heart muscle is unable to function properly or dies. The most common symptom is chest pain, often radiating to the left shoulder or angle of the jaw, crushing, central and associated with nausea and sweating. Many people with acute coronary syndromes present with symptoms other than chest pain, particularly, women, older patients, and patients with diabetes mellitus.

Acute coronary syndrome is commonly associated with three clinical manifestations, named according to the appearance of the electrocardiogram (ECG): ST elevation myocardial infarction (STEMI, 30%), non-ST elevation myocardial infarction (NSTEMI, 25%), or unstable angina (38%). There can be some variation as to which forms of myocardial infarction (MI) are classified under acute coronary syndrome.
24 months after the date of randomization.
Number of participants with coronary or periphery artery disease requiring revascularization
기간: 24 months after the date of randomization.
Conronary or periphery artery diseases, regardless stable or not, need revascularization by stent which require long-term aspirin therapy
24 months after the date of randomization.

2차 결과 측정

결과 측정
측정값 설명
기간
Number of participants with device-related thrombus
기간: 24 months after the date of randomization.
This refers to the thrombus that is related to the implantation of the device for left atrial appendage closure. Transesophageal echocardiography is effective in identifying and diagnosing device-related thrombus.
24 months after the date of randomization.
Number of participants with minor bleedings
기간: 24 months after the date of randomization.
Minor bleedings refer to the bleedings acoording to the TIMI cirteria
24 months after the date of randomization.
Number of Participants with hospitalization due to heart failure
기간: 24 months after the date of randomization.
Patients need to receive treatments in hospital because of occurrence of heart failure or deterioration of heart failure.
24 months after the date of randomization.
Number of participants with all-cause death
기간: 24 months after the date of randomization.
any cause of death
24 months after the date of randomization.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

수사관

  • 수석 연구원: Yi-Gang Li, Dr., Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 6월 1일

기본 완료 (예상)

2022년 6월 1일

연구 완료 (예상)

2024년 12월 1일

연구 등록 날짜

최초 제출

2019년 1월 22일

QC 기준을 충족하는 최초 제출

2019년 1월 27일

처음 게시됨 (실제)

2019년 1월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 10월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 10월 9일

마지막으로 확인됨

2021년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • XH-18-017

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Aspirin Tablet에 대한 임상 시험

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건강 상태

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정황

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약물 개입

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스폰서 / 협력자

위치

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