Assessment of an Alpha-glucosidase Inhibitor to Block Cardiac Events in Patients With MI and IGT
The Japan Working Group for the Assessment That the Alpha-glucosidase Inhibitor Blocks Cardiac Events in Patients With Myocardial Infarction and IGT
연구 개요
상세 설명
Type 2 diabetes mellitus is a well-established risk factor for coronary heart disease and atherosclerotic change in the coronary artery develops subclinically in a state of impaired glucose tolerance (IGT). Recently postprandial hyperglycemia as a feature of impaired glucose tolerance is recognized as a significant risk factor for coronary heart disease. So we designed a prospective randomized multi-center trial named Assessment of an α-glucosidase-inhibitor to Block Cardiac Events in Patients With Myocardial Infarction and IGT (ABC study) to evaluate whether an α-Glucosidase Inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with IGT and old myocardial infarction.
100 hospitals will participate in the ABC study. Patients with IGT who have a history of prior myocardial infarction are randomly allocated to receive α-Glucosidase Inhibitor (voglibose) or a standard diet and exercise treatment. The number of patients to be recruited is 3000 and this study will continue for at least 2 years. The primary end-points are:
- cardiovascular mortality and
- hospitalization for cardiovascular events.
Effects in suppression of new diabetes development will also be evaluated.
We should recognize IGT as an important therapeutic target to decrease the recurrence of cardiovascular events. The ABC study, a large scale multi-center trial in Japan, will provide us with new evidence on how to treat IGT patients with prior myocardial infarction.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Osaka
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Suita, Osaka, 일본, 565-8565
- National Cardiovascular Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Impaired glucose tolerance
- History of myocardial infarction
Exclusion Criteria:
- Type I diabetes
- History of coronary artery bypass graft
- Severe liver and/or kidney dysfunction
- History of allergic response to drugs
- Arteriosclerosis obliterans
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: the voglibose group
Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals.
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활성 비교기: the control group
Participants assigned to the control group were treated only with diet and exercise therapy.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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the time till the first cardiovascular composite endpoint of death from cardiovascular death, and hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina[16], nonfatal stroke, or treatment with coronary revascularisation
기간: May 2005 and June 2012
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the time till the first cardiovascular composite endpoint of death from the time till the first cardiovascular composite endpoint of death from cardiovascular death, and hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina[16], nonfatal stroke, or treatment with coronary revascularisation
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May 2005 and June 2012
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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All cause mortality
기간: May 2005 and June 2012
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All cause death
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May 2005 and June 2012
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Hospitalization due to coronary artery disease
기간: May 2005 and June 2012
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Hospitalization due to coronary artery disease
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May 2005 and June 2012
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Progression of IGT to diabetes
기간: May 2005 and June 2012
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Progression of IGT to diabetes
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May 2005 and June 2012
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Development or deterioration of either hypertension or hyperlipidemia
기간: May 2005 and June 2012
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Development or deterioration of either hypertension or hyperlipidemia
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May 2005 and June 2012
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Deterioration of renal function
기간: May 2005 and June 2012
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Deterioration of renal function
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May 2005 and June 2012
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Hospitalization due to cerebrovascular disease
기간: May 2005 and June 2012
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Hospitalization due to cerebrovascular disease
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May 2005 and June 2012
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Hospitalization due to heart failure
기간: May 2005 and June 2012
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Hospitalization due to heart failure
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May 2005 and June 2012
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CSSCJ-3
- UMIN_ID:C000000090
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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