Table 2.
No. | Study | Study design | Sponsor | Country | Sample size | Follow-up (months) | Interventions | Male n (%) | Mean age (SD) | CAD n (%) | PAD n (%) | History of stroke/CV disease n (%) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | CAPRIE [19] | Multicentre, double blind | Sanofi and Bristol-MyersSquibb | International (Australia, Austria, Belgium, Canada, Finland, France, Germany, Italy, Netherlands, New Zealand, Portugal, Spain, Sweden, Switzerland, UK, USA) | 19,185 | Mean: 22.9 | Clopidogrel 75 mg od | (72) | 62.5 (11.1) | – | – | [9] |
ASA 325 mg od | (72) | 62.5 (11.1) | – | – | [9] | |||||||
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2 | CHARISMA, NCT00050817 [1] | Multicentre, double blind, phase III study | Sanofi-Aventis and Bristol-Myers Squibb | International (Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UK, USA) | 15,603 | Median: 28 | Clopidogrel 75 mg od+ASA 75-162 mg od | 5,486 (70.3) | – | 2,892 (47.70) | 1,760 (22.60) | 2,157 (35.60) |
ASA 75-162 mg od | 5,473 (70.2) | – | 2,943 (48.30) | 1,771 (22.70) | 2,163 (35.50) | |||||||
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3 | COMPASS, NCT01776424 [15] | Multicentre, double blind, phase III study | Bayer | International (Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland, Ukraine, UK, USA) | 27,395 | Mean: 23 | Rivaroxaban 5 mg bid | 7,145 (78.4) | 68.2 (7.9) | 8,250 (90.50) | 2,474 (27.10) | 346 (3.80) |
Rivaroxaban 2.5 mg bid+ASA 100 mg od | 7,093 (77.5) | 68.3 (7.9) | 8,313 (90.80) | 2,492 (27.20) | 351 (3.80) | |||||||
ASA 100 mg od | 7,137 (78.2) | 68.2 (8.0) | 8,261 (90.50) | 2,504 (27.40) | 335 (3.70) | |||||||
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4 | TRA 2°P–TIMI 50, NCT00526474 [20] | Multicentre, double blind, phase III study | Merck | International (Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Sweden, Switzerland, UK, USA) | 26,449 | Median: 30 | Vorapaxar 2.5 mg od | 10,071 (76.2) | – | 8,898 (67.3) | 2,901 (21.9) | 3,139 (23.70) |
Placebo | 10,052 (76.0) | – | 8,881 (67.2) | 2,944 (22.3) | 3,129 (23.70) |
ASA: acetylsalicylic acid; bid: bis in die = twice a day; CAD: coronary artery disease; CV: cardiovascular; od: once a day; PAD: peripheral artery disease.