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| Name | Class |
|---|---|
| CSPC Pharmaceutical Group Limited | INDUSTRY |
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This study is a prospective, randomized, placebo-double-blind, multicenter clinical trial. The purpose of this study is to investigate whether "butylphthalide +PCI" combined treatment mode on the basis of traditional drug therapy could reduce myocardial infarct size, improve cardiac function and long-term prognosis of patients with acute myocardial infarction, and verify the drug safety of butylphthalide in the treatment of STEMI within the window period of 12 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Butylphthalide group | Experimental | The Butylphthalide group received 100ml of butylphthalide injection twice a day for 7±2 days, followed by butylphthalide soft capsules (2 capsules, three times a day) from the day of discharge to day 30±2. |
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| Placebo group | Placebo Comparator | The placebo group received 100ml of butylphthalide placebo injection twice a day for 7±2 days, followed by butylphthalide placebo soft capsules (2 capsules, three times a day) from the day of discharge to day 30±2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butylphthalide | Drug | Subjects who were initially diagnosed with STEMI and scheduled for PCI were randomly assigned to one of two groups in a 1:1 ratio: a butylphthalide group and a placebo group. |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy in reducing myocardial infarct size in subjects with STEMI after primary PCI | To evaluate the efficacy of butylphthalide injection versus placebo in reducing myocardial infarct size at day 30 in patients with STEMI after primary PCI. | 30±2 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of no-reflow and severe slow flow events | The proportion of no-reflow and severe slow flow events on day 30±2 after randomization (TFG<2 is defined as slow flow events and angiographic score). | 30±2 days post-randomization |
| The changes of ST-segment resolution in electrocardiogram |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Le Zhang | Contact | 86+13973187150 | zlzdzlzd@csu.edu.cn |
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The subjects will be randomly assigned in a 1:1 ratio to two groups: a butylphthalide group and a placebo group.The Butylphthalide group received 100ml of butylphthalide injection twice a day for 7±2 days, followed by butylphthalide soft capsules (2 capsules, three times a day) from the day of discharge to day 30±2. The placebo group received the same dosage of butylphthalide injection and soft capsules placebo.
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| Butylphthalide placebo | Drug | Butylphthalide placebo |
|
ST-segment resolution of electrocardiogram at 7±2 days and 30±2 days after randomization. |
| 7±2 days and 30±2 days post-randomization |
| CMR imaging cardiac function indexes and cardiac color Doppler ultrasound related indexes | CMR examination of microcirculation obstruction area, delayed enhancement phenomenon, left ventricular ejection fraction (LVEF%) and other CMR imaging cardiac function indicators and cardiac color Doppler ultrasound related indicators. | 30±2 days post-randomization |
| The decline of myocardial enzyme indexes | Myocardial enzyme indexes (CK-MB, troponin I or T) decline at 7±2 days and 30±2 days of randomization. | 7±2 days and 30±2 days post-randomization |
| Proportion of combined vascular events | Rate of combined vascular events (symptomatic stroke, recurrent myocardial infarction, vascular death) at 30±2 days after randomization. | 30±2 days post-randomization |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| 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 |
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| ID | Term |
|---|---|
| C027125 | 3-n-butylphthalide |
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