Table 1

Characteristics of randomised controlled trials evaluating novel antithrombotic agents in various medical conditions

Study nameStudy populationPrimary endpointCoronary eventStudy drug and dose (number of subjects)Control drug and dose (number of subjects)Duration of therapyJadad score
Venous thromboembolism prophylaxis
 EXULT A7Knee surgeryVTE, deathNRXimelagatran
36 mg twice daily (n=629)
24 mg twice daily (n=614)
Warfarin (n=608)7–12 days5
 EXULT B8Knee surgeryVTE, deathNRXimelagatran
36 mg twice daily (n=982)
Warfarin (n=967)7–12 days5
 RE-NOVATE9Hip surgeryVTE, deathACSDabigatran
150 mg once daily (n=874)
220 mg once daily (n=880)
Enoxaparin
40 mg once daily (n=897)
28–35 days5
 RE-MODEL10Knee surgeryVTE, deathACSDabigatran
150 mg once daily (n=526)
220 mg once daily (n=503)
Enoxaparin
40 mg once daily (n=512)
6–10 days5
 RE-MOBILIZE11Knee surgeryVTE, deathcardiac events*Dabigatran
150 mg once daily (n=649)
220 mg daily (n=604)
Enoxaparin
30 mg twice daily (n=643)
14† (12–15) days5
 RE-NOVATE II12Hip surgeryVTE, deathMIDabigatran
220 mg once daily (n=792)
Enoxaparin
40 mg once daily (n=785)
28–35 days5
 RECORD113Hip surgeryVTE, deathMIRivaroxaban
10 mg daily (n=1595)
Enoxaparin
40 mg daily (n=1558)
36† (30–42) days5
 RECORD214Hip surgeryVTE, deathMIRivaroxaban
10 mg daily (n=1252)
Enoxaparin
40 mg daly (n=1257)
30–42 days5
 RECORD315Knee surgeryVTE, deathMIRivaroxaban
10 mg daily (n=1254)
Enoxaparin
40 mg daily (n=1277)
13–17 days5
 RECORD416Knee surgeryVTE, deathMIRivaroxaban
10 mg daily (n=965)
Enoxaparin
30 mg twice daily (n=959)
13–17 days5
 ADVANCE 117Knee surgeryVTE, deathMIApixaban
2.5 mg twice daily (n=1599)
Enoxaparin
30 mg twice daily (n=1596)
10–14 days5
 ADVANCE 218Knee surgeryVTE, deathMIApixaban
2.5 mg twice daily (n=1528)
Enoxaparin
40 mg daily (n=1529)
10–14 days5
 ADVANCE 319Hip surgeryVTE, deathMIApixaban
2.5 mg twice daily (n=1949)
Enoxaparin
40 mg daily (n=1917)
35 days5
Treatment of venous thromboembolism
 THRIVE20Acute VTE therapyRecurrent VTEACSXimelagatran
36 mg twice daily (n=1240)
Enoxaparin followed by warfarin (n=1249)6 months5
 RE-COVER21VTE therapyVTEACSDabigatran
150 mg twice daily (n=1273)
Parenteral anticoagulation then warfarn (n=1266)6 months5
 RE-SONATE22Extended VTE therapyRecurrent VTE, related deathCV eventsDabigatarn
150 mg twice daily (n=681)
Placebo (n=662)6 months3‡
 REMEDY23Extended VTE therapyRecurrent VTE, related deathACSDabigatran
150 mg twice daily (n=1430)
Warfarin (n=1426)6–36 months3‡
 EINSTEIN24Symptomatic DVT therapyRecurrent VTEACSRivaroxaban
15 mg twice daily for 3 weeks, then 20 mg daily (n=1718)
Heparin followed by warfarin (n=1711)3, 6, 12 months5
Prevention of embolic events in atrial fibrillation
 SPORTIF III25Non-valvular atrial fibrillationStroke and embolic eventsMIXimelagatran
36 mg twice daily (n=1704)
Warfarin (n=1703)17.4 months§3
 SPORTIF V26Non-valvular atrial fibrillationStroke and embolic eventsMIXimelagatran
36 mg twice daily (n=1960)
Warfarin (n=1962)20 months§5
 RE-LY27Non-valvular atrial fibrillationStroke and embolic eventsMIDabigatran
110 mg twice daily (n=6015)
150 mg twice daily (n=6076)
Warfarin (n=6022)2 years†3
 ROCKET AF28Non-valvular atrial fibrillationStroke or embolic eventsMIRivaroxaban
20/15 mg daily (n=6958)
Warfarin (n=7004)707 days†5
 AVERROES29Atrial fibrillation warfarin unsuitableStroke or embolic eventsMIApixaban
5/2.5 mg twice daily (n=2808)
Aspirin
81–324 mg daily (n=2791)
1.1 years§5
 ARISTOTLE30Atrial fibrillation/flutterStroke or embolic eventsMIApixaban
5/2.5 mg twice daily (n=9120)
Wafarin (n=9081)1.8 years†5
Treatment of acute coronary syndrome
 RE-DEEM31STE or NSTE MICV death, MI, strokeACSDabigatran
50 mg twice daily (n=369)
75 mg twice daily (n=368)
110 mg twice daily (n=406)
150 mg twice daily (n=347)
Placebo (n=371)6 months5
 ATLAS ACS 2 TIMI 5132Unstable angina, STE or NSTE MICV death, MI, strokeCV death or MIRivaroxaban
2.5/5 mg twice daily (n=10 229)
Placebo (n=5113)13 months§5
 APPRAISE33Unstable angina, STE or NSTE MICV death, MI, re-ischemia or ischemic strokeCV death or MIApixaban
10 mg daily (n=315)
2.5 mg twice daily (n=315)
Placebo (n=599)6 months5
 APPRAISE 234Unstable angina, STE or NSTE MICV death, MI, strokeACSApixaban
5 mg twice daily (n=3705)
Placebo (n=3687)240 days†5
  • *Cardiac events, specifics were not provided but events were reviewed by a blinded independent committee.

  • †Median.

  • ‡Limited information available.

  • §Mean.

  • VTE, venous thromboembolism; NR, not reported; ACS, acute coronary syndrome (consisting of unstable angina, myocardial infarction and cardiac death); MI, myocardial infarction; CV, cardiovascular; STE, ST-segment-elevation; NSTE, non-ST-segment-elevation

  • Acronyms for studies, where applicable: EXULT, Exanta Used to Lessen Thrombosis; RECORD, Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism; ADVANCE, Apixaban Dose Orally versus. Anticoagulant with Enoxaparin; THRIVE, the Thrombin Inhibitor in Venous Thromboembolism; SPORTIF, Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation; RE-LY, Randomized Evaluation of Long-Term Anticoagulation Therapy; ROCKET AF; Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; AVERROES, Apixaban Versus Acetylsalicylic Acid to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment; ARISTOTLE, Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; ATLAS ACS 2-TIMI 51, Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis in Myocardial Infarction 51; APPRAISE, Apixaban for Prevention of Acute Ischemic and Safety Events Trial.