ELISA-2 (Early or Late Intervention in unStable Angina)

ISRCTN	ISRCTN87763194
DOI	https://doi.org/10.1186/ISRCTN87763194
Protocol serial number	NL77, NTR108
Sponsor	Isala klinieken, locatie Weezenlanden, Dept of Cardiology (The Netherlands)
Funder	Not provided at time of registration

Submission date: 12/09/2005
Registration date: 12/09/2005
Last edited: 05/08/2021

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

Mr J. Klijn
Scientific

Diagram B.V. Zwolle
Zwolle
-
Netherlands

Phone	+31 (0)38 4262997
Email	j.klijn@diagram-zwolle.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	ELISA-2 (Early or Late Intervention in unStable Angina)
Study acronym	ELISA-2
Study objectives	In patients presenting with a non-ST elevation acute coronary syndrome with (new) ST segment depression and/or positive troponin-T, who undergo PCI, treatment with a dexamethason coated stent will reduce the incidence of restenosis at 6 month follow-up angiography.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Unstable angina pectoris, acute coronary syndrome
Intervention	Angiography and Revascularisation (PCI) after 24 hours pre-treatment with Tirofiban compared to Angiography after Pre-Treatment with Clopidogrel in High Risk Patients with Unstable Angina.
Intervention type	Other
Primary outcome measure(s)	Enzymatic infarct size
Key secondary outcome measure(s)	1.Enzymatic Infarct Size (LDHQ72) 2. Hospital Stay - Total duration in hospital in days, including admission and discharge day Do Dexamethason-coated Stents Decrease the incidence of Restenosis in patients with an Acute Coronary Syndrome? 3. Clinical endpoints 3.1 Death - Total mortality will be assessed at 30 days follow-up. 3.2 Myocardial Infarction a. Early MI in patients presenting with CKmb > upper limit of normal. b. Early MI in patients presenting with CKmb not exceeding the upper limit of normal c. Late MI in patients whose CKmb has returmed to (or has remained) normal. d. MI in patients who underwent CABG. 3.3 Stroke - All (hemorrhagic and non-hemorrhagic) strokes must be confirmed by CT scan examination and after consultation of a neurologist. 3.4 Bleeding 4. Secondary Efficacy Parameter 4.1 The Tirofiban strategy results in a better patency of the culprit coronary artery before intervention. 4.2 Coronary Angiography. All angiography films will be evaluated by an independent core-laboratory (DIAGRAM, Zwolle, the Netherlands), without access to clinical data.
Completion date	01/04/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	330
Total final enrolment	328
Key inclusion criteria	At least 2 out of 3 of the following: 1. Ischemic Chest Pain at rest with last attack < 24 hours 2. Evidence of myocardial Ischemia on ECG 3. (New) ST depression > 0,1 mVolt in 2 leads 4. Evidence of myocardial damage 5. Positive Troponin (>0.05 microgr/l) or Myoglobin (>200 microg/l) on admission or 3 hours later 6. Positive CPKmb fraction on admission
Key exclusion criteria	1. Aged <50 or >80 years 2. Persistent ST segment elevation 3. Cardiogenic Shock or pulmonary edema 4. Myocardial ischemia precipitated by non-cardiac condition (anemia, hyperthyroidism) 5. PTCA within previous 6 months 6. Renal failure/Liver failure
Date of first enrolment	01/04/2002
Date of final enrolment	01/04/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Diagram B.V. Zwolle

Zwolle
-
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/06/2006	05/08/2021	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/08/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.