No registrations found.
ID
Source
Brief title
Health condition
Acute coronary syndrome.
Sponsors and support
Dept of Cardiology
Isala Klinieken, locatie Weezenlanden
Groot Wezenland 20
8011 JW, Zwolle, the Netherlands
Intervention
Outcome measures
Primary outcome
The Tirofiban strategy results in a smaller enzymatic infarct size, compared to the Clopidogrel strategy.
Secondary outcome
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
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.
Background summary
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.
Study objective
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.
Study design
N/A
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.
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
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 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL77 |
| NTR-old | NTR108 |
| Other | : |
| ISRCTN | ISRCTN87763194 |