Clinical trial NCT02419833: Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients
Official title: Randomized Study of ImmeDiate Versus DeLayEd Invasive Intervention in Patients With Non ST-segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: non-STEMI
immediate
delayed
PCI
Lead sponsor: Clinical Centre of Serbia
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite of all-cause death or myocardial reinfarction
timeFrame: within 30 days of randomization
Secondary outcomes:
measure: Composite of all-cause death, myocardial reinfarction or recurrent ischemia
timeFrame: within 30 days of randomization
measure: All-cause mortality
timeFrame: within 30 days, 1, 3 and 5 years after randomization
measure: Myocardial reinfarction
timeFrame: within 30 days, 1, 3 and 5 years after randomization
measure: Stroke
timeFrame: within 30 days, 1, 3 and 5 years after randomization
measure: Recurrent ischemia
timeFrame: within 30 days of randomization
measure: Major bleeding
timeFrame: within 30 days, 1, 3 and 5 years after randomization
measure: Duration of index hospitalization
timeFrame: at 30-day follow-up, the duration of hospital stay is assessed
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia, Department of Cardiology
Study officials:
affiliation: Clinical Centre of Serbia
name: Goran Stankovic, MD, PhD
role: STUDY_DIRECTOR
affiliation: Clinical Centre of Serbia
name: Aleksandra Milosevic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Centre of Serbia
name: Zorana Vasiljevic, MD, PhD
role: STUDY_CHAIR
References:
citation: Milosevic A, Vasiljevic-Pokrajcic Z, Milasinovic D, Marinkovic J, Vukcevic V, Stefanovic B, Asanin M, Dikic M, Stankovic S, Stankovic G. Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients: The RIDDLE-NSTEMI Study. JACC Cardiovasc Interv. 2016 Mar 28;9(6):541-9. doi: 10.1016/j.jcin.2015.11.018. Epub 2016 Jan 6.