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
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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 measure
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 (if study stopped)
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
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., Pfizer Consumer Healthcare
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
Basic results (scientific)
Publication list
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
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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.
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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.
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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.
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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.
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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.
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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.
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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.