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Completed

NCT Number: NCT03974581

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

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.

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Key information

Conditions

Myocardial Infarction, Acute Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Cardiología "Ignacio Chavez"

Mexico City, 14030, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary percutaneous coronary intervention

Other

Patient receives primary percutaneous coronary intervention as part of his treatment; decision to allocate by treating physician.

Other names: Primary PCI

Pharmacoinvasive strategy

Other

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.

Primary outcomes

  1. Composite of cardiovascular mortality + cardiogenic shock + reinfarction + stroke.

    Time frame: 30-days follow-up.

    Main efficacy combined outcome including cardiovascular mortality, cardiogenic shock, reinfarction and stroke.

Secondary outcomes

  1. Major bleeding

    Time frame: Major bleeding during a 30-days follow-up.

    Major bleeding during a 30-days follow-up.

  2. All-cause mortality

    Time frame: 1-year follow up.

    All cause mortality at 1-year follow up.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Other

Registry information

Official study title

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

Acronym: PHASE-MX

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 5, 2019
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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