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Prevention of Thromboembolic Events in Total Knee Replacement Patients

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ClinicalTrials.gov Identifier: NCT03393481
Recruitment Status : Not yet recruiting
First Posted : January 8, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)

Condition or disease Intervention/treatment Phase
Thrombotic Disorders Drug: MAA868 Drug: Enoxaparin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Open-label, blinded endpoint assessment
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Active-controlled Phase 2 Study to Compare the Efficacy and Safety of s.c. MAA868 Versus s.c. Enoxaparin in Adult Patients Undergoing Unilateral Total Knee Arthroplasty
Estimated Study Start Date : October 3, 2018
Estimated Primary Completion Date : January 8, 2020
Estimated Study Completion Date : April 17, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MAA868 dose 1
MAA868 dose 1, single administration, subcutaneous
Drug: MAA868
MAA868 dose 1 and dose 2, single administration, subcutaneous,

Experimental: MAA868 dose 2
MAA868 dose 2, single administration, subcutaneous
Drug: MAA868
MAA868 dose 1 and dose 2, single administration, subcutaneous,

Active Comparator: Enoxaparin
Enoxaparin 40mg, once daily (o.d.) for 10 days
Drug: Enoxaparin
Enoxaparin 40 mg, o.d X 10 days




Primary Outcome Measures :
  1. Number of patients with confirmed composite endpoint [ Time Frame: Day 14 ]
    Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death


Secondary Outcome Measures :
  1. Number of patients with composite bleeding [ Time Frame: Day 1 to Day 50 ]
    Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events

  2. Number of patients with composite venous thromboembolic events (VTE) [ Time Frame: Day 1 to Day 110 ]
    Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
  • Willing to comply with study requirements including bilateral venography at Day 12 ± 2 days
  • Body weight between 50 kg and 130 kg inclusive.
  • Normal aPTT, PT, INR at screening

Exclusion Criteria:

History of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP ≥ 150/95 mmHg at the screening).

Medications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR < 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C >10%); Liver dysfunction (ALT/AST >3 xULN or TBL >2 x ULN); BMI ≥ 40 kg/m2


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393481


Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03393481     History of Changes
Other Study ID Numbers: CMAA868A2201
2017-002925-39 ( EudraCT Number )
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
biologic,
venous thromboembolism,
unilateral knee arthroplasty

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases