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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Osaka
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Suita、Osaka、日本、565-8565
- National Cardiovascular Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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アクティブコンパレータ：the control group
Participants assigned to the control group were treated only with diet and exercise therapy.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：May 2005 and June 2012
|
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
|
May 2005 and June 2012
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
All cause mortality
時間枠：May 2005 and June 2012
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All cause death
|
May 2005 and June 2012
|
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Hospitalization due to coronary artery disease
時間枠：May 2005 and June 2012
|
Hospitalization due to coronary artery disease
|
May 2005 and June 2012
|
|
Progression of IGT to diabetes
時間枠：May 2005 and June 2012
|
Progression of IGT to diabetes
|
May 2005 and June 2012
|
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Development or deterioration of either hypertension or hyperlipidemia
時間枠：May 2005 and June 2012
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Development or deterioration of either hypertension or hyperlipidemia
|
May 2005 and June 2012
|
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Deterioration of renal function
時間枠：May 2005 and June 2012
|
Deterioration of renal function
|
May 2005 and June 2012
|
|
Hospitalization due to cerebrovascular disease
時間枠：May 2005 and June 2012
|
Hospitalization due to cerebrovascular disease
|
May 2005 and June 2012
|
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Hospitalization due to heart failure
時間枠：May 2005 and June 2012
|
Hospitalization due to heart failure
|
May 2005 and June 2012
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CSSCJ-3
- UMIN_ID:C000000090
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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