Pharmacoinvasive Strategy vs. Primary PCI in STEMI: A Prospective Registry in a Large Geographical Area

Myocardial Infarction, Acute Clinical Trial

— PHASE-MX  

Official title:

Pharmacoinvasive Strategy vs. Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction: A Prospective, Real-World Registry in a Large Geographical Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974581
• Other study ID #: PT-19-021
• Status: Completed
• Start date: April 30, 2018
• Est. completion date: July 14, 2020

Study information

• Verified date: July 2020
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

For patients presenting with ST-elevation myocardial infarction (STEMI), immediate and timely reperfusion treatment is essential. Pharmacoinvasive strategy (PIs) exploits the widespread availability of fibrinolysis and its early administration to restore some degree of myocardial blood flow, coupled with the complete restoration of the culprit coronary artery patency that can be obtained with subsequent angioplasty. Several trials have demonstrated the efficacy and safety of PIs when compared with PPCI; however, real-world data is lacking, especially in developing countries.

The aim of this study was to compare safety and efficacy of PIs with PPCI in real-world patients with STEMI presenting to large geographical area.

Description:

For patients presenting with ST-elevation myocardial infarction (STEMI), immediate and timely reperfusion treatment is essential. The optimal choice between primary percutaneous coronary intervention (PPCI) and intravenous thrombolytic agents depends upon the timeliness of effective delivery, as well as the total ischemic time. While PPCI is widespread available in the USA and Europe, limited resources and lack of infrastructure means that patients with STEMI in low- and middle-income countries (LMICs) receive significantly less reperfusion therapy, and when they do, they are more prone to receive thrombolytic agents.

Pharmacoinvasive strategy (PIs) exploits the widespread availability of fibrinolysis and its early administration to restore some degree of myocardial blood flow, coupled with the complete restoration of the culprit coronary artery patency that can be obtained with subsequent angioplasty. Several trials have demonstrated the efficacy and safety of PIs when compared with PPCI; however, real-world data is lacking. The aim of this study was to compare safety and efficacy of PIs with PPCI in real-world patients with STEMI presenting to large geographical area.

PHASE-Mx study is a prospective, real-world registry including patients with STEMI finally treated at a large cardiovascular center. In brief, patients aged 18-99 years old with the diagnosis of STEMI whom received either PI or PPCI during the first 12 hours since symptom onset were included. Patients could have a first medical contact directly at the study center or in one of other 60 hospitals along the STEMI network. Patients with a discharge diagnosis other than STEMI were excluded. Four of the investigators recorded the study data at admission and during hospital stay. Main efficacy outcome will be the composite of cardiovascular death, cardiogenic shock, reinfarction or stroke. Main safety outcome will include rates of major bleeding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 14, 2020
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-99 years old, with the diagnosis of STEMI whom received either PI or PPCI during the first 12 hours since symptom onset. Patients could have a first medical contact directly at the study center or in one of other 60 hospitals along the STEMI network.

Exclusion Criteria:

• Patients with a discharge diagnosis other than STEMI.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute

Intervention

Other:
• Primary percutaneous coronary intervention
Patient receives primary percutaneous coronary intervention as part of his treatment; decision to allocate by treating physician.
• Pharmacoinvasive strategy
Patient receives primary fibrinolysis and subsequent coronary angiography (pharmacoinvasive strategy) as part of his treatment; cases with failed fibrinolysis are scheduled for immediate rescue PCI. Decision to allocate by treating physician.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cardiología "Ignacio Chavez"	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of cardiovascular mortality + cardiogenic shock + reinfarction + stroke.	Main efficacy combined outcome including cardiovascular mortality, cardiogenic shock, reinfarction and stroke.	30-days follow-up.
Secondary	Major bleeding	Major bleeding during a 30-days follow-up.	Major bleeding during a 30-days follow-up.
Secondary	All-cause mortality	All cause mortality at 1-year follow up.	1-year follow up.