NCT07124819 - Dimolegin® (60 mg) Given Once Daily in Patients Undergoing Total Hip or Knee Replacement Compared to Enoxaparin | Biotech Hunter

Enrollment

215

Participants

Timeline

Start Date

July 22, 2024

Primary Completion Date

January 14, 2025

Study Completion Date

January 14, 2025

Conditions

Arthroplasty, Replacement, HipArthroplasty, Replacement, KneeVenous Thromboembolism (VTE)Prevention

Interventions

DRUG

Sodium enoxaparin

"Subgroup 2A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive Clexane® subcutaneously administered 12±1 hours before surgery starting 6-10 hours after surgery everyday for 35±2 days.~Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive Clexane® subcutaneously administered 12±1 hours before surgery everyday for 14±1 days."

DRUG

Dimolegin

"Subgroup 1A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive Dimolegin® starting 6-10 hours after surgery everyday for 35±2 days.~Subgroup 1B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive Dimolegin® starting 6-10 hours after surgery everyday for 14±1 days."

DRUG

Dimolegin placebo

Subgroup 2A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive placebo Dimolegin® starting 6-10 hours after surgery everyday for 35±2 days. Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive placebo Dimolegin® starting 6-10 hours after surgery everyday for 14±1 days.

DRUG

Sodium enoxaparine placebo

"Subgroup 1A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive palcebo Clexane® subcutaneously administered 12±1 hours before surgery starting 6-10 hours after surgery everyday for 35±2 days.~Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive placebo Clexane® subcutaneously administered 12±1 hours before surgery everyday for 14±1 days."

Trial Locations (8)

Unknown

Bryansk City Hospital No. 1, Bryansk

I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow

Privolzhsky Research Medical University, Nizhny Novgorod

Rostov State Medical University, Rostov-on-Don

Ryazan State Medical University named after academician I.P. Pavlov, Ryazan

Samara Regional Clinical Hospital named after V.D. Seredavin, Samara

National Research Ogarev Mordovia State University, Saransk

Saratov State Medical University named after V. I. Razumovsky, Saratov

All Listed Sponsors

lead

Avexima Diol LLC

INDUSTRY