Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI

A Randomized Controlled Study of Reperfusion Strategies in Acute ST-segment Elevation Myocardial Infarction Under Conditions of Anticipated In-hospital Delay in Primary Percutaneous Coronary Intervention Strategy: the Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI (RAPID-STEMI)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07641231

Acronym

RAPID-STEMI

Enrollment

240

Registered

2026-06-11

Start date

2026-05-20

Completion date

2029-05-20

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

in-hospital fibrinolysis, STEMI, pharmacoinvasive strategy, myocardial infarction (MI), thrombolysis

Brief summary

This study aims at evaluating of the effectiveness of in-hospital thrombolysis for ST-segment elevation myocardial infarction in PCI centers under conditions of predicted in-hospital delay (\>60 min after admission in PCI-center) of PCI. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 2-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.

Interventions

DRUGSingle, weight-adjusted i.v. bolus of tenecteplase

Single, weight-adjusted i.v. bolus of tenecteplase in case of \>60 min in-hospital delay in PCI center

PROCEDUREcatheterisation

Standard primary PCI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age equal or greater than 18 years * "Symptom onset-randomization" time interval \<12 hours * Predicted "diagnosis-pPCI" time interval equal or greater than 120 minutes * Predicted "admission-pPCI" time interval equal or greater than 60 minutes * Informed consent received

Exclusion criteria

* Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and/or the inability to evaluate the study primary endpoint

Design outcomes

Primary

Measure	Time frame	Description
The number of observed patients with cardiovascular death, nonfatal stroke, and nonfatal AMI within 12 months for FAS.	From enrollment to the end of follow-up (12 months).	Participants achieved a response if they have cardiovascular death or nonfatal stroke, or nonfatal AMI at 12 months.

Secondary

Measure	Time frame
Number of patients with all-cause mortality	during hospitalization (assessed up to 10 days)
Number of patients with cardiovascular mortality	during hospitalization (assessed up to 10 days)
Number of patients with non-fatal MI	during hospitalization (assessed up to 10 days)
Number of patients with hemorrhagic stroke	during hospitalization (assessed up to 10 days)
Number of patients with major bleeding according to the BARC scale (type 3-5)	during hospitalization (assessed up to 10 days)
Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications )	during hospitalization (assessed up to 10 days)
Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications)	12 months

Countries

Russia

Contacts

CONTACTRimma Gulyan

rimmagulyan5@mail.ru+79152284043

STUDY_DIRECTORDmitry Pevzner, Doctor of Medical Sciences

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

PRINCIPAL_INVESTIGATORRimma Gulyan