Condition category
Circulatory System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
15/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr RJ de Winter

ORCID ID

Contact details

Academic Medical Center
Department of Cardiology
B2-137
PO Box 22660
Amsterdam
1100 DD
Netherlands
-
r.j.dewinter@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR442

Study information

Scientific title

Invasive versus Conservative Treatment in Unstable coronary Syndromes

Acronym

ICTUS

Study hypothesis

An early invasive strategy is superior to a selectively invasive strategy for patients who have acute coronary syndromes without ST-segment elevation and with an elevated cardiac troponin T level.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute coronary syndrome

Intervention

Against a background of optimized medical therapy patients are randomized between an early invasive strategy or a selective invasive strategy.

The early invasive strategy includes angiography within 24 to 48 hours after randomization and revascularization when appropriate.

The selective invasive strategy includes medical stabilization, with angiography and revascularization only in case of refractory angina or significant ischemia on the pre-discharge exercise test.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Within one year after randomisation, a composite of:
1. Death
2. Non-fatal myocardial infarction
3. Rehospitalization for anginal symptoms

Secondary outcome measures

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

Overall trial start date

01/07/2001

Overall trial end date

01/09/2008

Reason abandoned

Eligibility

Participant 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
2. An elevated cardiac troponin T level (>/= 0.03 ug per litre)
3. Either ischemic changes as assessed by electrocardiography defined as ST-segment depression or transient ST-segment elevation exceeding 0.05 mV
4. Or T-wave inversion of >/= 0.2 mV in two contiguous leads
5. Or a documented history of coronary artery disease as evidenced by previous myocardial infarction
6. Findings on previous coronary angiography, or a positive exercise test

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1200

Participant 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
4. Hemodynamic instability or overt congestive heart failure
5. The use of oral anticoagulant drugs in the past 7 days
6. Fibrinolytic treatment within the past 96 hours
7. Percutaneous coronary intervention within the past 14 days
8. A contraindication to treatment with percutaneous coronary intervention or glycoprotein IIb/IIIa inhibitors
9. Recent trauma or risk of bleeding
10. Hypertension despite treatment and weight greater than 120 kg

Recruitment start date

01/07/2001

Recruitment end date

01/09/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Interuniversity Cardiology Institute of the Netherlands (ICIN) (Netherlands)

Sponsor details

PO Box 19258
Utrecht
3501 DG
Netherlands

Sponsor type

University/education

Website

http://www.icin.nl

Funders

Funder type

Industry

Funder name

Medtronic BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer (Netherlands)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Sanofi-Aventis (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Eli Lilly (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16162880
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17350451
3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18361193
4. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20045278
5. 2012 collaborative analysis in http://www.ncbi.nlm.nih.gov/pubmed/21930723
6. 2012 collaborative analysis in http://www.ncbi.nlm.nih.gov/pubmed/22199015
7. 2014 substudy results in http://www.ncbi.nlm.nih.gov/pubmed/24502880

Publication citations

  1. Results

    de Winter RJ, Windhausen F, Cornel JH, Dunselman PH, Janus CL, Bendermacher PE, Michels HR, Sanders GT, Tijssen JG, Verheugt FW, , Early invasive versus selectively invasive management for acute coronary syndromes., N. Engl. J. Med., 2005, 353, 11, 1095-1104, doi: 10.1056/NEJMoa044259.

  2. Results

    Hirsch A, Windhausen F, Tijssen JG, Verheugt FW, Cornel JH, de Winter RJ, , Long-term outcome after an early invasive versus selective invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome and elevated cardiac troponin T (the ICTUS trial): a follow-up study., Lancet, 2007, 369, 9564, 827-835, doi: 10.1016/S0140-6736(07)60410-3.

  3. Results

    Windhausen F, Hirsch A, Tijssen JG, Verheugt FW, Cornel JH, de Winter RJ, [Early invasive strategy no better than a selective invasive strategy for patients with non-ST-segment elevation acute coronary syndromes and elevated cardiac troponin T levels: long-term follow-up results of the ICTUS trial]., Ned Tijdschr Geneeskd, 2008, 152, 8, 437-444.

  4. Results

    Damman P, Hirsch A, Windhausen F, Tijssen JG, de Winter RJ, , 5-year clinical outcomes in the ICTUS (Invasive versus Conservative Treatment in Unstable coronary Syndromes) trial a randomized comparison of an early invasive versus selective invasive management in patients with non-ST-segment elevation acute coronary syndrome., J. Am. Coll. Cardiol., 2010, 55, 9, 858-864, doi: 10.1016/j.jacc.2009.11.026.

  5. Collaborative analysis

    Damman P, Clayton T, Wallentin L, Lagerqvist B, Fox KA, Hirsch A, Windhausen F, Swahn E, Pocock SJ, Tijssen JG, de Winter RJ, Effects of age on long-term outcomes after a routine invasive or selective invasive strategy in patients presenting with non-ST segment elevation acute coronary syndromes: a collaborative analysis of individual data from the FRISC II - ICTUS - RITA-3 (FIR) trials., Heart, 2012, 98, 3, 207-213, doi: 10.1136/heartjnl-2011-300453.

  6. Collaborative analysis

    Damman P, Wallentin L, Fox KA, Windhausen F, Hirsch A, Clayton T, Pocock SJ, Lagerqvist B, Tijssen JG, de Winter RJ, Long-term cardiovascular mortality after procedure-related or spontaneous myocardial infarction in patients with non-ST-segment elevation acute coronary syndrome: a collaborative analysis of individual patient data from the FRISC II, ICTUS, and RITA-3 trials (FIR)., Circulation, 2012, 125, 4, 568-576, doi: 10.1161/CIRCULATIONAHA.111.061663.

  7. Results

    Damman P, Kempf T, Windhausen F, van Straalen JP, Guba-Quint A, Fischer J, Tijssen JG, Wollert KC, de Winter RJ, Hirsch A; ICTUS investigators, Growth-differentiation factor 15 for long-term prognostication in patients with non-ST-elevation acute coronary syndrome: an Invasive versus Conservative Treatment in Unstable coronary Syndromes (ICTUS) substudy, Int J Cardiol, 2014, 172, 2, 356-363, doi: 10.1016/j.ijcard.2014.01.025.

Additional files

Editorial Notes