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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PLATO study design<br />
NSTE-ACS (moderate-to-high risk) STEMI (if primary PCI)<br />
Clopidogrel-treated or -naive;<br />
r<strong>and</strong>omised with<strong>in</strong> 24 hours <strong>of</strong> <strong>in</strong>dex event<br />
(N=18,624)<br />
Clopidogrel<br />
If pre-treated, no additional load<strong>in</strong>g dose;<br />
if naive, st<strong>and</strong>ard 300 mg load<strong>in</strong>g dose,<br />
then 75 mg qd ma<strong>in</strong>tenance;<br />
(additional 300 mg allowed pre PCI)<br />
Ticagrelor<br />
180 mg load<strong>in</strong>g dose, then<br />
90 mg bid ma<strong>in</strong>tenance;<br />
(additional 90 mg pre-PCI)<br />
6–12-month exposure<br />
Primary endpo<strong>in</strong>t: CV death + MI + Stroke<br />
Primary safety endp<strong>in</strong>t: Total major bleed<strong>in</strong>g<br />
PCI = percutaneous coronary <strong>in</strong>tervention; ASA = acetylsalicylic acid;<br />
CV = cardiovascular; TIA = transient ischaemic attack