Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Mr J. Klijn
ORCID ID
Contact details
Diagram B.V. Zwolle
Zwolle
-
Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ELISA-2
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
The Tirofiban strategy results in a smaller enzymatic infarct size, compared to the Clopidogrel strategy.
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 trial start date
01/04/2002
Overall trial end date
01/04/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
330
Participant exclusion criteria
1. 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
Recruitment start date
01/04/2002
Recruitment end date
01/04/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Diagram B.V. Zwolle
Zwolle
-
Netherlands
Sponsor information
Organisation
Isala klinieken, locatie Weezenlanden, Dept of Cardiology (The Netherlands)
Sponsor details
Groot Wezenland 20
Zwolle
8011 JW
Netherlands
+31 (0)38 4242374
hof@diagram-zwolle.nl
Sponsor type
Not defined
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
References:
1. Lowe HC, Oesterle SN, Khachigian LV. Coronary in-stent restenosis: current status and strategies. J Am Coll Cardiol 2002;39:183¡V93.
2. Serruys PW, De Jaegere P, Kiemeneij F, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. BENESTENT Study Group. N Engl J Med 1994;331:489¡V95.
3. Fischman DL, Leon M, Baim DS, et al. A randomised comparison of coronary-stent implantation and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Group Investigators. N Engl J Med 1994;331:496¡V501.
4. Versaci F, Gaspardone A, Tomai F, et al. A comparison of coronaryartery stenting with angioplasty for isolated stenosis of the proximal left anterior descending coronary artery. N Engl J Med 1997;336:817¡V 22.
5. Dussailant GR, Mintz GS, Pichard AD, et al. Small stent size and intimal hyperplasia contribute to restenosis: a volumetric intravascular ultrasound study. J Am Coll Cardiol 1995;26:720¡V4.
6. Hoffman R, Mintz GS, Dussailant GR, et al. Patterns and mechanisms of in-stent restenosis. A serial intravascular ultrasound study. Circulation 1996;94:1247¡V54.
7. Mudra H, Regar E, Klauss V, et al. Serial follow-up after optimized ultrasound-guided deployment of Palmaz-Schatz stents. In-stent neointimal proliferation without significant reference segment response. Circulation 1997;95:363¡V70.
8. Shirotani M, Yui Y, Kawai C. Restenosis after coronary angioplasty: pathogenesis of neointimal thickening initiated by endothelial loss. Endothelium 1993;1:5¡V22.
9. Forrester JS, Fishbein M, Helfant R, Fagin J. A paradigm for restenosis based on cell biology: clues for the development of new preventive therapies. J Am Coll Cardiol 1991;17:758¡V69.
10. Pietersma A, Kofflard M, de Wit EA, et al. Late lumen loss after coronary angioplasty is associated with the activation status of circulating phagocytes before treatment. Circulation 1995;91:1320¡V5.
11. De Servi S, Mazzone A, Ricevuti G, et al. Granulocyte activation after coronary angioplasty in humans. Circulation 1990;82:140¡V6.
12. Kornowoski R, Hong MK, Tio FO, Bramwell O, Wu H, Leon MB.In-stent restenosis: contributions of inflammatory responses and arterial injury to neointimal hyperplasia. J Am Coll Cardiol 1998;31:224¡V30.
13. Helle M, Boeije L, Pascaual-Salcedo D, Aarden L. Differential induction of interleukin-6 production by monocytes, endothelial cells and smooth muscle cells. Progr Clin Biol Res 1991;367:61¡V71.
14. Jang Y, Lincoff AM, Plow EF, Topol EJ. Cell adhesion molecules in coronary artery disease. J Am Coll Cardiol 1994;24:1591¡V601.
15. Ikeda U, Ikeda M, Oohara T, et al. Interleukin-6 stimulates growth of vascular smooth muscle cells in a PDGF-dependent manner. Am J Physiol 1991;250:1713¡V7.
16. Gauldie J, Richards C, Harnish D, Lansdorp P, Baumann H. Interferon-_2/B-cell stimulatory factor type 2 shares identity with monocyte-derived hepatocyte stimulating factor and regulates the major acute phase protein response in liver cells. Proc Natl Acad Sci U S A 1987;84:7251¡V5.
17. Gaspardone A, Crea F, Versaci F, et al. Predictive value of C-reactive protein after successful coronary artery stenting in patients with stable angina. Am J Cardiol 1998;82:515¡V8.
18. Walter DH, Fichtlscherer S, Sellwig M, Auch-Schwelk W, Scha¨chinger V, Zeiher AM. Preprocedural C-reactive protein levels and cardiovascular events after coronary stent implantation. J Am Coll Cardiol 2001;37:839¡V46.
19. MacDonald RG, Panush RS, Pepine CJ. Rationale for use of glucocorticoids in modification of restenosis after percutaneous transluminal coronary angioplasty. Am J Cardiol 1987;60:56B¡V60B.
20. Stone GW, Rutherford BD, McConahay DR, et al. A randomized trial of corticosteroids for the prevention of restenosis in 102 patients undergoing repeat coronary angioplasty. Cathet Cardiovasc Diagn 1989;18:227¡V31.
21. Pepine CJ, Hirshfeld JW, MacDonald RG, et al. A controlled trial of corticosteroids to prevent restenosis after coronary angioplasty. Circulation 1990;81:1753¡V61.
22. Lee CW, Chae J, Lim H, et al. Prospective randomized trial of corticosteroids for the prevention of restenosis after intracoronary stent implantation. Am Heart J 1999;138:60¡V