ELISA-2 (Early or Late Intervention in unStable Angina)
ISRCTN | ISRCTN87763194 |
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DOI | https://doi.org/10.1186/ISRCTN87763194 |
Secondary identifying numbers | NL77, NTR108 |
- 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
Scientific
Diagram B.V. Zwolle
Zwolle
-
Netherlands
Phone | +31 (0)38 4262997 |
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j.klijn@diagram-zwolle.nl |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Not Specified |
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 | Enzymatic infarct size |
Secondary outcome measures | 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. |
Overall study start date | 01/04/2002 |
Completion date | 01/04/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 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
-
Netherlands
Sponsor information
Isala klinieken, locatie Weezenlanden, Dept of Cardiology (The Netherlands)
Not defined
Not defined
Groot Wezenland 20
Zwolle
8011 JW
Netherlands
Phone | +31 (0)38 4242374 |
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hof@diagram-zwolle.nl | |
https://ror.org/046a2wj10 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 |
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.