ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

GlaxoSmithKline343 enrolled

Overview

The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

343

Conditions

Arthroplasty

Interventions

SB-424323DRUG

500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days

PlaceboDRUG

matching placebo, oral, BID for 28 days

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side). * Patients who have given written informed consent to participate in this study. Exclusion Criteria: * Patients with a contraindication to contrast venography * Patients with an increased risk of bleeding. * Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia. * Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

Outcomes

Primary Outcomes

VTE

Incidence of VTE during the 28-day treatment period, including death due to VTE

Time frame: 28 day treatment period

Secondary Outcomes

types of VTE

The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE\] and anti-IIa activity

Time frame: 28 day treatment period

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.