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治験 NCT07198191 (SGLT2i-AMI)（対象：急性心筋梗塞 (AMI)、2型糖尿病 (T2DM)）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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延世大学校SGLT2 Inhibitor Use After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Nationwide Cohort Study (SGLT2i-AMI) 200,000 RWE 観察研究
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07198191 (SGLT2i-AMI) は 観察研究 臨床試験 で、急性心筋梗塞 (AMI)、2型糖尿病 (T2DM) に関するものです。現在は 実施中／登録終了 で、2014年9月1日 から開始しています。200,000 名の参加者 の募集が計画されています。この試験は 延世大学校 によって主導され、2026年8月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月30日 です。
概要
This observational, retrospective cohort study aims to evaluate the impact of sodium-glucose cotransporter 2 (SGLT2) inhibitor use after acute myocardial infarction (AMI) in patients with type 2 diabetes mellitus (T2DM). Using the nationwide database from the Korean National Health Insurance Service, the investigators will compare cardiovascular outcomes between patients treated with SGLT2 inhibitors and those treate...もっと見る
詳細説明
Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated substantial cardiovascular benefits in patients with heart failure and chronic kidney disease, independent of glucose-lowering effects. However, their role in patients with acute myocardial infarction (AMI), particularly in the early post-infarction period, has been less clear. Recently, the DAPA-MI and EMPACT-MI randomized controlled trials have pro...もっと見る
公式タイトル
Impact of Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor Use After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Nationwide Population Cohort Study
疾患名
急性心筋梗塞 (AMI)2型糖尿病 (T2DM)その他の研究識別子
- SGLT2i-AMI
- IRB No. 9-2023-0049
NCT番号
開始日
2014-09-01
最終更新日
2025-09-30
終了予定日
2026-08-30
目標参加者数
200,000
試験の種類
観察研究
状況
実施中／登録終了
キーワード
SGLT2 inhibitor
Dapagliflozin
Empagliflozin
DPP4 inhibitor
Cardiovascular Outcomes
Heart Failure
Real-world Evidence
NHIS
South Korea
Dapagliflozin
Empagliflozin
DPP4 inhibitor
Cardiovascular Outcomes
Heart Failure
Real-world Evidence
NHIS
South Korea
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
SGLT2 Inhibitor Group Patients with type 2 diabetes mellitus (T2DM) who were prescribed SGLT2 inhibitors after acute myocardial infarction. | SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) Exposure to SGLT2 inhibitors following AMI in patients with T2DM |
DPP4 Inhibitor Group Patients with type 2 diabetes mellitus (T2DM) who were prescribed DPP4 inhibitors after acute myocardial infarction. | DPP4 inhibitors Exposure to DPP4 inhibitors following AMI in patients with T2DM |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Incidence of Major Adverse Cardiovascular Events (MACE) | MACE defined as a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke. | From index date (hospitalization for AMI), upto 365 days |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Incidence of Cardiovascular Death | Death from cardiovascular causes, including sudden cardiac death, myocardial infarction, heart failure, or stroke. | From index hospitalization for acute myocardial infarction, upto 365 days |
Incidence of All-cause Death | Death from any cause during follow-up. | From index hospitalization for acute myocardial infarction, upto 365 days |
Incidence of Non-fatal Myocardial Infarction | Hospitalization with a primary diagnosis of myocardial infarction (ICD-10 I21-I22), excluding fatal events. | From index hospitalization for acute myocardial infarction, upto 365 days |
Incidence of Non-fatal Ischemic Stroke | Hospitalization with a primary diagnosis of ischemic stroke, excluding fatal events. | From index hospitalization for acute myocardial infarction, upto 365 days |
Incidence of Hospital Admission for Heart Failure | Hospitalization with a primary diagnosis of heart failure | From index hospitalization for acute myocardial infarction, upto 365 days |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
19 Years
対象性別
全て
- Adults aged ≥19 years
- Hospitalization with a primary diagnosis of acute myocardial infarction between September 2014 and June 2021
- Diagnosis of type 2 diabetes mellitus (T2DM)
- Prescription of either an SGLT2 inhibitor or a DPP4 inhibitor after index AMI
- Diagnosis of type 1 diabetes mellitus
- Gestational diabetes mellitus
- End-stage renal disease (ESRD) or history of kidney transplantation
- No use of either SGLT2 inhibitor or DPP4 inhibitor after index AMI
- Short-term use of SGLT2 inhibitor or DPP4 inhibitor (less than 30 days)
- Concomitant use of SGLT2 inhibitor and DPP4 inhibitor
- Incomplete or missing data for key study variables
延世大学校200 件のアクティブな治験を探索- 鍾根堂製薬
- Health Insurance Review & Assessment Service
責任者
Yongcheol Kim, 主任研究者, Principal Investigator, Yonsei University
連絡先情報がありません。
1 1カ国の場所
Gyeonggi-do
Yongin Severance Hospital, Yonsei University Health System, Yongin, Gyeonggi-do, 16995, South Korea