Examples of ethnicity and geography issues in global clinical trials ...
Examples of ethnicity and geography issues in global clinical trials ...
Examples of ethnicity and geography issues in global clinical trials ...
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Trial Design<br />
Placebo<br />
NSTE Acute Coronary<br />
Syndromes<br />
1:1<br />
R<strong>and</strong>omized<br />
Double-bl<strong>in</strong>d<br />
Key <strong>in</strong>clusion criteria<br />
• With<strong>in</strong> 24 hrs <strong>of</strong> symptoms<br />
• biomarkers or ECG changes<br />
• 1 other high-risk feature<br />
Vorapaxar<br />
Load<strong>in</strong>g: 40 mg<br />
Ma<strong>in</strong>tenance: 2.5 mg daily<br />
Follow-up: 1, 4, 8, 12 months, then every 6 months<br />
St<strong>and</strong>ard <strong>of</strong> care based on practice guidel<strong>in</strong>es<br />
Efficacy Endpo<strong>in</strong>ts<br />
Primary: CV death, MI, stroke, hospitalization for ischemia, urgent revascularization<br />
Key Secondary: CV death, MI, stroke<br />
Bleed<strong>in</strong>g Endpo<strong>in</strong>ts: GUSTO moderate or severe <strong>and</strong> cl<strong>in</strong>ically significant TIMI bleed<strong>in</strong>g
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