A Randomized Controlled Trial on the Efficacy and Safety of Butylphthalide in Reducing Myocardial Infarction Size and Improving Outcomes in STEMI Patients After Primary PCI (RISE)

A Randomized Controlled Trial on the Efficacy and Safety of Butylphthalide in Reducing Myocardial Infarction Size and Improving Outcomes in STEMI Patients After Primary PCI - A Prospective, Multicenter, Randomized, Placebo, Double-blinded End Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
• Intervention / Treatment: Drug: Butylphthalide; Drug: Butylphthalide placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Le Zhang; Phone Number: 86+13973187150; Email: zlzdzlzd@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age range of 18-75 years, encompassing both genders;
2. Patients presenting with an initial clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI), within a maximum time frame of 12 hours from the onset of pain to consideration for trial inclusion, who fulfill the criteria for percutaneous coronary intervention (PCI) and express their intention to undergo PCI;
3. The subject and their legal representative possess the capacity and willingness to provide informed consent by signing.

Exclusion Criteria:

1. Uncontrolled hypertension (systolic blood pressure≥200mmHg and/or diastolic blood pressure≥110mmHg);
2. Previous PCI or CABG;
3. Long-term use of loading doses of anticoagulant or antiplatelet drugs;
4. History of hemorrhagic stroke or ischemic stroke within 6 months, peptic ulcer, prolonged cardiopulmonary resuscitation (more than 10 minutes) within the last 6 weeks, surgery, or major trauma;
5. Known allergy to butylphthalide or excipients;
6. Patients with any of the following conditions: cardiogenic shock, chronic congestive heart failure NYHA class ≥III, severe hypotension, pulmonary insufficiency, severe hepatic and renal insufficiency;
7. History of congenital or acquired hemorrhagic diseases, coagulation factor deficiency diseases, thrombocytopenic diseases, etc. Or any of the following laboratory tests (INR > 2.0, platelet count < 100×109/L, Hb < 10g/dl);
8. Pregnancy, lactation, and planning to become pregnant within 30 days;
9. Severe mental disorder, alcohol dependence or inability to cooperate with informed consent and follow-up due to dementia;
10. Concurrent malignant tumor or severe systemic disease with expected survival time less than 30 days;
11. Have participated in or are currently participating in another clinical intervention study within 30 days before randomization;
12. Other reasons for not being eligible for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Butylphthalide 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.	Drug: Butylphthalide; 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.
Placebo Comparator: Placebo group; 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.	Drug: Butylphthalide placebo; Butylphthalide placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Collaborators: CSPC Pharmaceutical Group Limited

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; ST Elevation Myocardial Infarction; Myocardial Infarction; Infarction; Physiological Effects of Drugs; Platelet Aggregation Inhibitors; Protective Agents; Neuroprotective Agents; 3-n-butylphthalide
• Other Study ID Numbers: 202409176

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No