Invasive versus Conservative Treatment in Unstable coronary Syndromes

ISRCTN	ISRCTN82153174
DOI	https://doi.org/10.1186/ISRCTN82153174
Protocol serial number	NTR442
Sponsor	Interuniversity Cardiology Institute of the Netherlands (ICIN) (Netherlands)
Funders	Medtronic BV (Netherlands), Pfizer (Netherlands), Sanofi-Aventis (Netherlands), Eli Lilly (Netherlands)

Submission date: 27/01/2006
Registration date: 27/01/2006
Last edited: 15/01/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr RJ de Winter
Scientific

Academic Medical Center
Department of Cardiology
B2-137
PO Box 22660
Amsterdam
1100 DD
Netherlands

Email	r.j.dewinter@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Invasive versus Conservative Treatment in Unstable coronary Syndromes
Study acronym	ICTUS
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Within one year after randomisation, a composite of: 1. Death 2. Non-fatal myocardial infarction 3. Rehospitalization for anginal symptoms
Key secondary outcome measure(s)	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
Completion date	01/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1200
Key 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
Key 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
Date of first enrolment	01/07/2001
Date of final enrolment	01/09/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/09/2005		Yes	No
Results article	results	10/03/2007		Yes	No
Results article	results	23/02/2008		Yes	No
Results article	results	02/03/2010		Yes	No
Results article	substudy results	15/03/2014		Yes	No
Other publications	collaborative analysis	31/01/2012		Yes	No
Other publications	collaborative analysis	01/02/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes