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| ID | Type | Description | Link |
|---|---|---|---|
| DAFLO | Registry Identifier | DAFLO-CH |
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Dapagliflozin is one of the SGLT-2 inhibiters. Recent clinical trials have demonstrated that SGLT-2 inhibitors are effective for treating heart failure. The DAPA-HF clinical trial has demonstrated that the effects of empagliflozin and dapagliflozin improve renal outcomes and reduce all-cause and cardiovascular death in patients with HFrEF[1]. However, its effect on myocardial infarction, the most common disease leading to death in the population, has not been evaluated sufficiently. A meta-analysis has demonstrated that compared with the control, SGLT2 inhibitor is associated with a reduction in the incidence of major adverse cardiovascular events (MACEs), myocardial infarction, cardiovascular mortality and all-cause mortality[2]. It seems that dapagliflozin might be effective for patients with acute myocardial infarction based on these studies. Thus, this study aims to evaluate the effect of dapagliflozin on short-term prognosis in patients with acute myocardial infarction compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Dapagliflozin 10 mg every 24 hours for 12 months |
|
| Control Group | Other | AMI standard therapy for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10mg/Tab | Drug | patients meeting inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE events | To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes in post-infarction patients during the follow-up time. | 12 months |
| Post-infarction angina | Evaluate the post-infarction angina occurence in both groups | 12 months |
| The rate of heart failure occurrence | Assess the rate of new-onset heart failure during the study follow-up. | 12 months |
| IL-6 | Serum IL-6 level | baseline, 1 month, 3 month, 6 month, 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| IL-1β | Serum IL-1β | baseline, 1 month, 3 month, 6 month, 12 month |
| hs-CRP | hs-CRP | baseline, 1 month, 3 month, 6 month, 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weisheng Liu, MD | Qingdao Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mengmei Li | Qingdao | Shandong | 266042 | China |
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| control group | Drug | patients meeting the inclusion criteria will be randomized to receive AMI standard therapy every 24 hours for 12 months. |
|
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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