NCT04962178

Evaluate Early Invasive Strategy for Patients With STEMI Presenting 24-48 Hours From Symptom Onset

A Randomized Multicenter Trial to Evaluate Early Invasive Strategy for Patients With Acute ST-segment Elevation Myocardial Infarction Presenting 24-48 Hours From Symptom Onset

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 366 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the trial is to evaluate the efficacy of early invasive strategy for STEMI patients within 24-48h of symptom onset.

Detailed description

At present, timely primary percutaneous coronary intervention (PCI) is the preferred strategy for ST-segment elevation myocardial infarction (STEMI) patients within 24h of symptom onset. In stable STEMI patients presenting 12 to 48 hours from symptom onset, BRAVE-2 Trial (n = 365) showed improved myocardial salvage and 4-year survival in patients treated with primary PCI compared with conservative treatment alone. However, data is scarce about the reperfusion strategy focusing on STEMI patients within 24-48h of symptom onset. Further investigations are warranted to explore the best timing of invasive strategy for STEMI patients within 24-48h of symptom onset. Given that no randomized clinical trial is designed especially for STEMI patients within 24-48h of symptom onset, and limited data is available to evaluate the efficacy of early invasive strategy for the special subgroup of STEMI patients, investigators plan to perform a controlled, randomized trial to evaluate the efficacy of early invasive strategy for STEMI patients within 24-48h of symptom onset.

Conditions

• ST-segment Elevation Myocardial Infarction (STEMI)

Interventions

Type	Name	Description
PROCEDURE	Primary PCI	The patients assigned to early invasive strategy group will receive the primary PCI.
OTHER	Optimal medical therapy with primary PCI not performed	The patients assigned to conservative strategy group will receive optimal medical therapy before primary endpoint accomplished.

Timeline

• Start date: 2021-09-09
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2021-07-14
• Last updated: 2022-06-24

Locations

1 site across 1 country: China