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Invasive versus Conservative Treatment in Unstable coronary Syndromes.

Invasive versus Conservative Treatment in Unstable coronary Syndromes.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23333
Enrollment
1200
Registered
2005-12-12
Start date
2001-07-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Acute coronary syndromes

Interventions

Against a background of optimized medical therapy patients are randomized between an early invasive strategy or a selective invasive strategy. The early invasive strategy include angiography within 2

Sponsors

The ICTUS trial is supported by educational grants from Eli Lilly, Sanofi-Synthelabo, Aventis, Pfizer, and Medtronic.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Symptoms of ischemia that were increasing or occurred at rest, with the last episode occurring no more than 24 hours before randomization; - an elevated cardiac troponin T level (≥0.03µg per liter); 2. and either ischemic changes as assessed by electrocardiography (defined as ST-segment depression or transient ST-segment elevation exceeding 0.05 mV, 3. or T-wave inversion of ≥0.2 mV in two contiguous leads) 4. or a documented history of coronary artery disease as evidenced by previous myocardial infarction, 5. findings on previous coronary angiography, or a positive exercise test.

Exclusion criteria

Exclusion criteria: 1. Age younger than 18 years or older than 80 years; 2. Myocardial infarction with ST-segment elevation in the past 48 hours; 3. An indication for primary percutaneous coronary intervention or fibrinolytic therapy, - hemodynamic instability or overt congestive heart failure; 4. The use of oral anticoagulant drugs in the past 7 days,; 5. Fibrinolytic treatment within the past 96 hours; 6. Percutaneous coronary intervention within the past 14 days; 7. A contraindication to treatment with percutaneous coronary intervention or glycoprotein IIb/IIIa inhibitors; 8. Recent trauma or risk of bleeding; 9. Hypertension despite treatment and weight greater than 120 kg.

Design outcomes

Primary

MeasureTime frame
The primary end point is 1. A composite of death; 2. Nonfatal myocardial infarction; 3. Or rehospitalization for anginal symptoms within one year after randomization.

Secondary

MeasureTime frame
1. The occurrence of the components of the primary endpoint; 2. The occurrence of death or myocardial infarction; 3. A percutaneous coronary intervention; 4. Coronary artery bypass grafting; 5. Functional status after one, six, and twelve months; 6. Two, three and five years follow-up.

Contacts

Public ContactR.J. Winter, de

Academic Medical Center (AMC), Department of Cardiology, B2-137, P.O. Box 22660

r.j.dewinter@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)