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…
ID
Bron
Verkorte titel
Aandoening
Acute coronary syndrome.
Ondersteuning
Dept of Cardiology
Isala Klinieken, locatie Weezenlanden
Groot Wezenland 20
8011 JW, Zwolle, the Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The Tirofiban strategy results in a smaller enzymatic infarct size, compared to the Clopidogrel strategy.
Achtergrond van het onderzoek
This 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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Wetenschappers
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
(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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL77 |
| NTR-old | NTR108 |
| Ander register | : |
| ISRCTN | ISRCTN87763194 |