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Table summary of clinical trials for ximelagatran
pdf
short list
Clinical trials of ximelagatran (ximelagatran, xi-melagatran, Exanta, H 376 95, H 376-95, ) are available for the clinical conditions:
DVT prophylaxis
These trials are included in meta-analysis concerning:
direct antithrombins in orthopedic surgery,
antithrombotics in orthopedic surgery,
antithrombotics in elective major knee surgery,
antithrombotics in elective hip replacement,
ximelagatran vs Dalteparin
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METHRO I ,2002
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Melagatran 1–4 mg s.c. immediately before surgery, melagatran at 20.00 hours, then ximelagatran 6–24 mg orally b.d. for 6–9 days
versus
Dalteparin 5000 IU o.d., started evening before surgery for 6–9 days
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adults undergoing hip or knee replacement
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Follow-up: 6–9 days
open
Swedish
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METHRO II ,2002
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Melagatran 1–3 mg s.c. immediately before surgery,melagatran same day, then ximelagatran 8–24 mg orally b.d. for 7–10 days
versus
Dalteparin 5000 IU o.d., started evening before surgery for 7–10 days
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undergoing hip or knee replacement
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Follow-up: 7–10 days
double-blind
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ximelagatran vs Enoxaparin
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Phase II (Heit) ,2001
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Ximelagatran 8, 12, 18 or 24 mgorally b.d., at least 12 h after surgery for 6–12 days
versus
Enoxaparin 30 mg s.c. b.d.,starting at least 12 h after surgery for 6–12 days
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adults (age>18 years and weight at least 40 kg) undergoing knee replacements
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Follow-up: 6–12 days
double-blind
North American
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Platinum (Colwell) ,2003
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Ximelagatran 24 mg orally b.d., starting at least 12 h after surgery for 7–12 days
versus
Enoxaparin 30 mg s.c. b.d.,starting at least 12 h after surgery for 7–12 days
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adults undergoing hip replacement
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Follow-up: 7–12 days
double-blind
USA, Canada, Israel, Mexico,Argentina, South Africa
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METHRO III ,2002
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Melagatran 3 mg s.c. 4–12h after surgery, then ximelagatran24 mg orally b.d. for 7–10 days
versus
Enoxaparin 40 mg s.c. o.d. 12 h before surgery for 7–10 days
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hip or knee replacement
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Follow-up: 8–11 days
double-blind
Europe, South Africa
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EXPRESS ,2003
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Melagatran 2 mg s.c. up to 30 min before surgery, then melagatran 3 mg at least 8 hafter surgery, then ximelagatran 24 mg orally b.d. for 8–11 days
versus
Enoxaparin 40 mg s.c. o.d.,starting 12 h before surgery for 8–11 days
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hip or knee replacement
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Follow-up: 8–11 days
double-blind
Europe
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Venous thrombosis
These trials are included in meta-analysis concerning:
antithrombotics in all type of patients,
new oral anticoagulants in all types of patients,
antithrombotics in secondary prevention of VTE,
direct factor Xa inhibitors in all type of patients,
antithrombotics in patients with cancer,
ximelagatran vs discontinuation
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THRIVE III ,2003
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ximelagatran 24 mg twice daily for 18 months
versus
placebo for 18 months
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patients with venous thromboembolism who had undergone six months of anticoagulant therapy
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Follow-up: 18 months
double blind
18 countries
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ximelagatran vs placebo
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Schulman (subgroup) ,2003
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extended treatment with Ximelagatran 24mg twice daily after initial anticoagulant treatment for 6 months
versus
placebo (initial anticoagulant treatment for 6 months)
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study subgroup of patients with active cancer in the previous 5 years treated for DVT or pulmonary
embolism for 6 months without recurrence
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Follow-up: 18 months
single blind and outcome ass.
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ximelagatran (without LMWH) vs LMWH/VKA
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THRIVE I ,2003
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oral ximelagatran (24, 36, 48 or 60 mg twice daily) for 2 weeks
versus
dalteparin and warfarin for 2 weeks
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Patients with acute DVT
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Follow-up:
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Fiessinger ,2005
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ximelagatran 36 mg twice daily
versus
subcutaneous enoxaparin, 1 mg/kg twice daily, for 5 to 20 days followed by warfarin adjusted to maintain an international normalized ratio of 2.0 to 3.0.
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patients with acute deep vein thrombosis
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Follow-up:
double blind
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Atrial fibrillation
These trials are included in meta-analysis concerning:
new oral anticoagulants in all type of patients,
antithrombotics in primary prevention of thromboembolic events,
direct antithrombins in all type of patients,
ximelagatran vs warfarin standard dose
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SPORTIF II (ximelagatran vs warfarin standard dose) ,2002
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ximelegatran 20,40,60 mg twice daily
versus
warfarin standard dose(target INR 2-3)
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Medium to high risk patients with chronic non valvular atrial fibrillation.
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Follow-up: 16 weeks
Open
Europe ,USA
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SPORTIF III ,2003
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ximelagatran 36 mg twice daily
versus
warfarin standard dose (target INR 2-3)
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One or more stroke risk factor in addition to AF.High risk patients with non valvular atrial fibrillation.
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Follow-up: 17.4 months
Open
europe,asia,australasia
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SPORTIF V ,2005
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ximelegatran 36 mg twice daily
versus
warfarin standard dose(target INR 2-3)
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One or more stroke risk factor in addition to atrial fibrillation.High risk patients with non valvular atrial fibrillation.
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Follow-up: 20 months
Double blind
north america
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Entry terms: xi-melagatran, ximelagatran, xi-melagatran, glycine, N-((1)1-cyclohexyl-2-((2)-((((4-(amino(hydroxyimino)methyl)phenyl)methyl)amino)carbonyl)-1-azetidinyl)2-oxoethyl)-ethyl ester, glycine, N-((1R)1-cyclohexyl-2-((2S)-((((4-(amino(hydroxyimino)methyl)phenyl)methyl)amino)carbonyl)-1-azetidinyl)2-oxoethyl)-ethyl ester, Exanta, H 376 95, H 376-95, melagatran, N-((R)-(((2S)-2-((-p-amidobenzyl)carbamoyl)-1-azetidinyl)carbonyl)cyclohexylmethyl)glycine
Search ximelagatran clinical trials in
Pubmed
Search ximelagatran clinical trials in
ClinicalTrials.gov
Search ximelagatran clinical trials in
Wikipedia
Search ximelagatran in
drugs.com
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