The FDA review on data quality and conduct in vorapaxar trials: Much better than in PLATO, but still not perfect

Author:

Serebruany Victor L.,Choi Sun Young,Kim Moo Hyun

Publisher

Elsevier BV

Subject

Cardiology and Cardiovascular Medicine

Reference12 articles.

1. Pharmacodynamics and pharmacokinetics of the novel PAR-1 antagonist vorapaxar (formerly SCH 530348) in healthy subjects;Kosoglou;Eur. J. Clin. Pharmacol.,2012

2. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes;Tricoci;N. Engl. J. Med.,2012

3. Vorapaxar in the secondary prevention of atherothrombotic events;Morrow;N. Engl. J. Med.,2012

4. Ticagrelor versus clopidogrel in patients with acute coronary syndromes;Wallentin;N. Engl. J. Med.,2009

5. The FDA Ticagrelor Secondary Review. Available for download at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM220192.pdf. (Assessed July 21st, 2015).

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