NCT03974581: PHASE-MX

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

Completed Last updated 15 July 2020

What this trial tests

trial testing Primary percutaneous coronary intervention in Myocardial Infarction, Acute in 500 participants. Completed in 14 July 2020.

Timeline

30 April 2018

Primary endpoint
14 July 2020

14 July 2020

Quick facts

Lead sponsor	Instituto Nacional de Cardiologia Ignacio Chavez
Status	Completed
Study type	OBSERVATIONAL
Enrollment	500
Start date	30 April 2018
Primary completion	14 July 2020
Estimated completion	14 July 2020
Sites	1 location across Mexico

Drugs / interventions tested

• Primary percutaneous coronary intervention
• Pharmacoinvasive strategy

Conditions studied

• Myocardial Infarction, Acute — all drugs for Myocardial Infarction, Acute →

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez — full company profile →

Who can join

Adults 18 to 99, any sex, with Myocardial Infarction, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacoinvasive Strategy vs Primary Percutaneous Coronary Intervention in Patients With ST-Elevation Myocardial Infarction: Results From a Study in Mexico City.
   Araiza-Garaygordobil D, Gopar-Nieto R, Cabello-López A, Martinez-Amezcua P, et al · · 2021 · cited 18× · PMID 34027343 · DOI 10.1016/j.cjco.2020.11.012
2. Pulmonary Congestion Assessed by Lung Ultrasound and Cardiovascular Outcomes in Patients With ST-Elevation Myocardial Infarction.
   Araiza-Garaygordobil D, Baeza-Herrera LA, Gopar-Nieto R, Solis-Jimenez F, et al · · 2022 · cited 9× · PMID 35620605 · DOI 10.3389/fphys.2022.881626
3. Real-World Evaluation of a Pharmacoinvasive Strategy for STEMI in Latin America: A Cost-Effective Approach with Short-Term Benefits.
   Arias-Mendoza A, Ortega-Hernández JA, Araiza-Garaygordobil D, González-Pacheco H, et al · · 2023 · cited 3× · PMID 38023623 · DOI 10.2147/tcrm.s432683
4. Adherence to optimal medical therapy and control of cardiovascular risk factors in patients after ST elevation myocardial infarction in Mexico.
   Villalobos-Pedroza M, Hernandez-Pastrana S, Arias-Mendoza A, Latapi-Ruiz Esparza X, et al · · 2024 · cited 2× · PMID 39114561 · DOI 10.3389/fcvm.2024.1384684
5. Adherence and persistence of optimal medical therapy after myocardial infarction in a low to middle income country
   Villalobos-Pedroza M, Flores-Batres A, Rivera-Pedrote E, Brindis-Aranda A, et al · · 2021
6. Efficacy and safety of pharmacoinvasive strategy compared with primary PCI in patients with STEMI presenting to non-PCI hubs: A real world study
   Gallardo-Grajeda A, Dattoli-Garcia C, Jackson-Pedroza C, Gopar-Nieto G, et al · · 2021
7. Time to percutaneous coronary intervention in patients with ST-elevation myocardial infarction undergoing successful systemic fibrinolysis: does early or late make a difference?
   Jackson-Pedroza C, Gallardo-Grajeda A, Dattoli-Alejo C, Gopar-Nieto R, et al · · 2021