Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Procedure: Timing of percutaneous coronary intervention

• Registration Number: NCT00402675
• Lead Sponsor: University of Leipzig

Brief Summary

In non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear.

Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test.

The optimal timing of intervention is still matter of debate as a result of a randomized clinical trial.

Detailed Description

In this randomized, controlled, open-label clinical trial we compare a very early cardiac catheterization (\< 2,5 hours after randomization) similar to ST-elevation myocardial infarction treatment, versus an early invasive approach (within 2-48 hours after randomization) versus a selective invasive approach in patients with non-ST-elevation myocardial infarction.

All patients are treated with heparin, ASA, Clopidogrel loading dose (600 mg) with subsequent 75 mg/d and tirofiban for 24 hours.

Study Timeline

• Study Start: 2006-07
• Status Verified: 2006-11
• Study First Submitted: 2006-11-20
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-22
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-04
• Last Update Posted: 2010-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Clinical symptoms:

   Instable angina pectoris:

   • Angina at rest < 24 hours
   • new onset worsening angina within the last weeks with angina at very low threshold < 24 h

2. Troponin T:

   Troponin T-elevation ≥ 0,03 μg/l

3. Informed consent

Exclusion Criteria

1. Age < 18 years
2. Age > 90 years
3. STEMI
4. Hemodynamic instability
5. Cardiogenic shock
6. Warfarin therapy
7. Contraindications for GpIIb/IIIa-inhibitors
8. life expectancy < 6 months
9. known high bleeding risk
10. Pregnancy
11. Other reasons for Troponin-elevation: Myocarditis, secondary after hypertensive crisis, cardiac decompensation
12. No informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immediate Intervention	Timing of percutaneous coronary intervention	Patients with NSTEMI undergo immediate invasive angiography (\< 2 hours)
Early Intervention	Timing of percutaneous coronary intervention	Patients with NSTEMI undergo early invasive angiography (12-48 hours)
Selective invasive angiography	Timing of percutaneous coronary intervention	Patients with NSTEMI undergo selective invasive angiography

Primary Outcome Measures

Name	Time	Method
peak creatine kinase- MB level	5 days

Secondary Outcome Measures

Name	Time	Method
Major bleeding complications (GUSTO definition)	30 days
Composite: death, re-myocardial infarction, recurrent unstable angina	6 months

Trial Locations

Locations (5)

Städt. Klinikum St. Georg; 🇩🇪 Leipzig, Germany

Krankenhaus der Barmherzigen Brüder; 🇩🇪 Regensburg, Germany

Klinikum Links der Weser; 🇩🇪 Bremen, Germany

University of Leipzig; 🇩🇪 Leipzig, Germany

University of Leipzig - Heart Center; 🇩🇪 Leipzig, Germany