Patients With Acute Coronary Syndrome Clinical Trial
Official title:
Prevalence of Inadequate Platelet Inhibition After Oral Loading With Prasugrel/Clopidogrel in Patients With an Acute Coronary Syndrome Undergoing Early PCI
Background: Both prasugrel and clopidogrel are prescribed drugs which compete as platelet
inhibitors in patients with acute coronary syndrome (ACS). Whether rates of drug
resistance/hyporesponsiveness are lower with prasugrel and whether more consistent and
earlier onset of platelet inhibition may reduce infarct size in patients with ACS undergoing
early PCI remains, at present, unknown.
Study design/study population: This trial is a prospective, open-label, single centre
observational trial. Patients receive either prasugrel (60mg) or clopidogrel (600mg) at the
discretion of the attending cardiologist. Patients with exclusion criteria for prasugrel
will be excluded for clopidogrel as well. The study population includes 80 subjects with
moderate to high-risk ACS, ie patients with unstable angina (UA) and non-ST-segment
elevation MI (NSTEMI) and TIMI risk score of 3 or higher, within 72 hours after onset of
symptoms. In all patients early PCI is planned.
Study objective/endpoint/methods: The primary objective of this trial is to evaluate whether
rates of hyporesponsiveness are lower with prasugrel and whether more consistent and earlier
onset of platelet inhibition may reduce infarct size in ACS in patients undergoing early
PCI.
The primary endpoint is the rate of drug resistance at time of index intervention. Optical
and impedance aggregometry using ADP (5 and 20 μM) and collagen (1 μg/ml) as platelet
agonists is used to measure platelet aggregation. Addition of the specific antagonists
aspirin and mesamp to the probe is used to discriminate between pharmacodynamic and
pharmacokinetic drug resistance.
Secondary endpoint is the reduction of myocardial infarct size determined by
post-interventional increase of high sensitive TnT (TnT hs) during the days following the
index event reflecting earlier, more effective and more consistent inhibition of platelet
function.
Tertiary endpoint is the composite clinical endpoint of cardiovascular death, nonfatal MI,
or stroke and urgent target vessel revascularization during hospitalization and after 6 and
12 months.
Safety endpoint is any TIMI major or minor bleeding during hospital stay and after 6 and 12
months including intracranial and life-threatening bleeding.
look above ;
Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01799148 -
Air Pollution, Inflammation and Acute Coronary Syndrome
|
N/A |