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


- candidate number1170
- NTR NumberNTR108
- ISRCTNISRCTN87763194
- Date ISRCTN created12-sep-2005
- date ISRCTN requested18-aug-2005
- Date Registered NTR2-aug-2005
- Secondary IDs 
- Public TitleELISA-2 (Early or Late Intervention in unStable Angina).
- Scientific TitleAngiography and Revascularisation after 24 hours pre-treatment with Tirofiban compared to Angiography after Pre-Treatment with Clopidogrel in High Risk Patients with Unstable Angina.
- ACRONYMELISA-2
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studiedUnstable angina pectoris, Acute coronary syndrome (ACS)
- 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:
(New) ST depression > 0,1 mVolt in 2 leads;
3. Evidence of myocardial damage:
Positive Troponin (>0.05 microgr/l) or Myoglobin (>200 microg/l) on admission or 3 hours later or;
4. Positive CPKmb fraction on admission.
- Exclusion criteria1. Age <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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2002
- planned closingdate1-apr-2005
- Target number of participants330
- InterventionsAngiography 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.
- Primary outcomeThe Tirofiban strategy results in a smaller enzymatic infarct size, compared to the Clopidogrel strategy.
- Secondary outcome1. 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

2.Secondary Efficacy Parameter
The Tirofiban strategy results in a better patency of the culprit coronary artery before intervention.
2.1Coronary Angiography
All angiography films will be evaluated by an independent core-laboratory (DIAGRAM, Zwolle, the Netherlands), without access to clinical data.
- TimepointsN/A
- Trial web sitehttp://www.diagram-zwolle.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES J. Klijn
- CONTACT for SCIENTIFIC QUERIESMD. PhD. A.W.J. Hof, van 't
- Sponsor/Initiator Isala Klinieken, Locatie Weezenlanden, Department of Cardiology
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsEur Heart J. 2006 Jun;27(12):1401-7. Epub 2006 May 8.
- Brief summaryThis is a randomised, open, single center study. It is designed to compare 2 treatment strategies in patients with a non-ST elevation acute coronary syndrome and (new) ST segment depression and/or positive troponin-T. It will investigate whether angiography and revascularisation with (24 hours) pre-treatment with a glycoprotein 2b/3a receptor blocker (Tirofiban strategy), reduces enzymatic infarct size compared to pre-treatment with a platelet aggregation inhibitor (Clopidogrel strategy).


Angiographic substudy:
Do Dexamethason-coated Stents Decrease the incidence of Restenosis in patients with an Acute Coronary Syndrome?
Patients will be randomised to blinded stent designs. Neither the operator, nor the patient will know whether the delivered stent is Dexamethason coated or non-coated.
- Main changes (audit trail)
- RECORD3-aug-2005 - 2-jul-2008


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