Overview

This trial is active, not recruiting.

Condition myocardial infarction
Treatments immediate invasive intervention, delayed invasive intervention, coronary artery stenting
Sponsor Clinical Centre of Serbia
Start date September 2009
End date March 2013
Trial size 323 participants
Trial identifier NCT02419833, 440/VII/1

Summary

In patients with acute myocardial infarction without ST-segment elevation on ECG (non-STEMI), previous studies have indicated that routine invasive treatment confers more benefit as compared to selective invasive approach. The benefits of routine invasive coronary intervention have been the most evident in patients with higher baseline risk profile. However, the question of optimal timing of routine invasive intervention remains unsolved.

Immediate invasive intervention early after admission for non-STEMI may limit myocardial necrosis by securing the patency of the culprit coronary artery. Nevertheless, several previous studies reported higher levels of biomarkers of myocardial injury in patients undergoing early PCI. The question of earlier versus delayed procedure in non-STEMI patients may thus amount to whether the risk of intervening on an unstable plaque is greater than the risk of new ischemic events while waiting for the invasive procedure.

The purpose of the present study is to compare effects of immediate coronary intervention, within 2 hours of admission, versus delayed intervention, within 2-72 hours after admission, in patients witn non-STEMI.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission
immediate invasive intervention
Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission
coronary artery stenting
Implantation of coronary stents
(Active Comparator)
Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and within 2-72 hours of admission
delayed invasive intervention
Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and/or within 2-72 hours of admission
coronary artery stenting
Implantation of coronary stents

Primary Outcomes

Measure
Composite of all-cause death or myocardial reinfarction
time frame: within 30 days of randomization

Secondary Outcomes

Measure
Composite of all-cause death, myocardial reinfarction or recurrent ischemia
time frame: within 30 days of randomization
All-cause mortality
time frame: within 30 days, 1, 3 and 5 years after randomization
Myocardial reinfarction
time frame: within 30 days, 1, 3 and 5 years after randomization
Stroke
time frame: within 30 days, 1, 3 and 5 years after randomization
Recurrent ischemia
time frame: within 30 days of randomization
Major bleeding
time frame: within 30 days, 1, 3 and 5 years after randomization
Duration of index hospitalization
time frame: at 30-day follow-up, the duration of hospital stay is assessed

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. episode of chest pain occurring no longer than 24 hours prior to admission 2. elevation of cardiac troponin I above the upper limit of normal (ULN) 3. new ST-segment depression at least 1 millivolt (mV) and/or T-wave inversion or transient ST-segment elevation in ≥ 2 contiguous leads Exclusion Criteria: 1. age < 18 years 2. persistent ST-segment elevation 3. hemodynamic instability 4. cardiogenic shock on admission 5. life-threatening ventricular arrhythmias on admission 6. refractory angina on admission 7. active bleeding 8. any contraindication for the use of dual antiplatelet therapy (DAPT) 9. presence of comorbidities with life expectancy < 6 months

Additional Information

Official title Randomized Study of ImmeDiate Versus DeLayEd Invasive Intervention in Patients With Non ST-segment Elevation Myocardial Infarction
Principal investigator Aleksandra Milosevic, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Clinical Centre of Serbia.