Time course of platelet reactivity in the acute phase of STEMI as measured with various platelet function studies

Completed

Conditions: Platelet reactivity
10011082

Registration Number: NL-OMON38015

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Patient must meet ALL of the following criteria:
• Males or females > 21 years of age and < 85 years with symptoms of acute myocardial infarction of more than 30 minutes but less than 12 hours.
• ST segment elevation of > 1 mV in 2 adjacent ECG leads, with cumulative ST- segment deviation of 6 mm or more.
• Patients should only be included if there is a reasonable expectation that PCI will be conducted within 1 hour.

Exclusion Criteria

1) Patients who are unable to give informed consent or have life expectancy of < 1year
2) Subjects who have received thrombolytic therapy within 24 hours before PCI or GpIIb/IIIa-inhibitors within the last 15 days or during the PCI
3) Subjects with a contra-indication to anticoagulation or at increased bleeding risk
a. Past or present history (<1 year) of bleeding from gastrointestinal (haematemesis) melena, frank bleed in stool or visible haematuria
b. Known platelet count (<100,00/mm3 ) or coagulopathy or platelet disorder.
c. History of major recent (<30 day) surgery or trauma
4) Known Hb <6.5 mmol/L11g/dl or HCT <33%

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Platelet function tests, including LTA, VerifyNow P2Y12, TEG, Multiplate, PFA<br /><br>(see appendix A)<br /><br>• Percentage platelet bound P-selectin expression (see appendix A)<br /><br>• Thrombin generation at high tissue factor concentration, at low tissue factor<br /><br>concentration and with microparticle reagens.<br /><br>• Coagulation factors: Full length tissue factor pathway inhibitor (FL-TFPI),<br /><br>total protein S, FVIII, vWF<br /><br>• Genetic variations associated with response to antiplatelet therapy and<br /><br>thrombus formation </p><br>

Secondary Outcome Measures