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

ISRCTN ISRCTN87763194
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

Study website

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific titleELISA-2 (Early or Late Intervention in unStable Angina)
Study acronymELISA-2
Study objectivesIn 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) studiedUnstable angina pectoris, acute coronary syndrome
InterventionAngiography 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 typeOther
Primary outcome measureEnzymatic infarct size
Secondary outcome measures1.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 date01/04/2002
Completion date01/04/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants330
Total final enrolment328
Key inclusion criteriaAt 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 criteria1. 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 enrolment01/04/2002
Date of final enrolment01/04/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Diagram B.V. Zwolle
Zwolle
-
Netherlands

Sponsor information

Isala klinieken, locatie Weezenlanden, Dept of Cardiology (The Netherlands)
Not defined

Groot Wezenland 20
Zwolle
8011 JW
Netherlands

Phone +31 (0)38 4242374
Email hof@diagram-zwolle.nl
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.