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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate Intervention

Patients with NSTEMI undergo immediate invasive angiography (\< 2 hours)

Group Type ACTIVE_COMPARATOR

Timing of percutaneous coronary intervention

Intervention Type PROCEDURE

Immediate, early or selective invasive angiography

Early Intervention

Patients with NSTEMI undergo early invasive angiography (12-48 hours)

Group Type ACTIVE_COMPARATOR

Timing of percutaneous coronary intervention

Intervention Type PROCEDURE

Immediate, early or selective invasive angiography

Selective invasive angiography

Patients with NSTEMI undergo selective invasive angiography

Group Type ACTIVE_COMPARATOR

Timing of percutaneous coronary intervention

Intervention Type PROCEDURE

Immediate, early or selective invasive angiography

Interventions

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Timing of percutaneous coronary intervention

Immediate, early or selective invasive angiography

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No