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
| Verified date | March 2010 |
| Source | Heidelberg University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 26 |
| Est. completion date | December 2011 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion criteria: - Patients with unstable angina or non-ST-elevation myocardial infarction with ischemic symptoms lasting 10 minutes or more and occurring within 72 hours before randomization, - A TIMI risk score of 3 or more, and - Either ST-segment deviation of 1 mm or more or elevated levels of a cardiac biomarker of necrosis. - Legal age (and =18 y) and competent mental condition to provide written informed consent Exclusion Criteria: - Patients with weight < 60 kg, age > 75 year or history of TIA, stroke or intracranial bleeding according to prasugrel contraindications - Clinical status forbid inclusion (eg cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, New York Heart Association class IV congestive heart failure etc) - Bleeding risk exclusion criteria including fibrin-specific and non-fibrin-specific fibrinolytic therapy for index event, active internal bleeding or history of bleeding diathesis or any clinical findings in the judgment of the investigator associated with an increased risk of bleeding - History of hemorrhagic stroke, intracranial neoplasm, arteriovenous malformation, or aneurysm - Ischemic stroke within 3 months prior to screening - Oral anticoagulation or INR greater than 1.5 at the time of screening - Platelet count of less than 100 000/mm3 at the time of screening - Anemia (hemoglobin <10 g/dL) at the time of screening - Prior/concomitant therapy with thienopyridine or daily treatment with nonsteroidal antiinflammatory drugs or cyclooxygenase-2 inhibitors - General exclusion criteria |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | University of Heidelberg | Heidelberg | Baden-Württemberg |
| Lead Sponsor | Collaborator |
|---|---|
| Heidelberg University | Daiichi Sankyo Europe, GmbH |
Germany,
Ivandic BT, Schlick P, Staritz P, Kurz K, Katus HA, Giannitsis E. Determination of clopidogrel resistance by whole blood platelet aggregometry and inhibitors of the P2Y12 receptor. Clin Chem. 2006 Mar;52(3):383-8. Epub 2006 Jan 19. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary endpoint is the rate of drug resistance at time of index intervention. | Platelet aggregation is determined by light transmission and impedance aggregometry as previoulsy described (Boris T. Ivandic, Philipp Schlick, Peter Staritz, Kerstin Kurz, Hugo A. Katus and Evangelos Giannitsis: Determination of Clopidogrel Resistance by Whole Blood Platelet Aggregometry and Inhibitors of the P2Y12 Receptor; Clinical Chemistry 52: 383-388, 2006) | Routinely, platelet aggregation is evaluated ideally daily up to 96 hours after index event. | Yes |
| Secondary | Secondary endpoint is the reduction of myocardial infarct size determined by post-interventional increase of high sensitive TnT (TnT hs). | Routinely, ideally daily until 96h after index event. | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01799148 -
Air Pollution, Inflammation and Acute Coronary Syndrome
|
N/A |