Antithrombotic in patients at risk for venous thromboembolism MedDRA version: 7 Level: LLT Classification code 10047249
Conditions
Interventions
Product Name: TTP889
Product Code: TTP889
Pharmaceutical Form: Capsule, hard
CAS Number: 660826-14-2
Current Sponsor code: TTP889
Other descriptive name: arylcarboxamide carboxylate
Concentration unit
Sponsors
TransTech Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (male or female and of any race) must be at least 18 years old. Female subjects must be postmenopausal (with amenorrhea for at least 2 years prior to study entry) or surgically sterile (tubal ligation, hysterectomy and/or bilateral oophorectomy). Female subjects must have a negative serum pregnancy test Patients must weigh at least 45 kg. Patients must have undergone reparative surgery within 72 hours after unilateral hip fracture, defined as fracture of the upper third of either femur. Patients must have started standard prophylactic treatment for VTE with LMWH or heparin before surgery (preoperative dosing) or within 24 hours after hip fracture surgery and continued treatment with LMWH or heparin for at least five days, but not more than nine days, after surgery. The last dose of LMWH or heparin must have been administered at least 12 hours, but not more than 48 hours, before dosing with study drug. The investigator and patient must agree on a plan to assure the completion of the Day 7 Interim Visit and Day 21 Final Visit. The patient must demonstrate the mental and physical ability and willingness to follow all study-specific instructions, understand the explanation of the study and be able to read, comprehend and sign the Ethics Committee-approved informed consent form before initiation of any study-specific procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Evidence of active bleeding. Clinical signs of VTE. Any medical requirement for (or intention to use) continued anticoagulation after randomization through the end of study. Bleeding tendency after the current hip fracture surgery. Known bleeding disorder or diathesis. Any history of intracranial bleeding or hemorrhagic stroke or gastrointestinal bleeding within 3 months of study start. The presence of active malignant disease. Hip fracture associated with multiple trauma, that places the patient at excessive risk for hemorrhage or organ system failure, or that may make it difficult or impossible to perform bilateral lower limb venography. The intention to take aspirin at doses greater than 325 mg/day. [Note: The use of non-steroidal anti-inflammatory drugs (NSAIDS) should be discouraged, but is not cause for exclusion.] Hemoglobin 3.0 times the upper limit of normal (ULN) or an elevated total bilirubin > 1.5 times the ULN at the screening visit. Creatinine > 180 mmol/L (2.0 mg/dL) at the screening visit. Any other laboratory value at the screening visit that is outside the laboratory-specified normal (reference) range and considered by the investigator to be a clinically significant abnormality that warrants the exclusion of the patient from the study. Previous allergy to contrast material or any other contraindication or foreseen difficulties to perform bilateral lower limb venography. The use of an investigational drug of any kind within 28 days or 5 times the elimination half-life of the drug (whichever is longer) of initial dosing of study drug. Patient is currently breast-feeding a child and wishes to continue breast feeding. Having any other medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antithrombotic efficacy of TTP889, administered once daily for three weeks, in patients who have completed standard prophylactic treatment for deep vein thrombosis after hip fracture surgery. To evaluate the safety of TTP889.;Secondary Objective: To evaluate the safety of TTP889, administered once daily for three weeks, in patients who have completed standard prophylactic treatment for deep vein thrombosis after hip fracture surgery. To assess the possible correlation between peak and trough plasma concentrations of TTP889 and clinical safety and efficacy outcomes. ;Primary end point(s): The primary efficacy endpoint is the occurrence of VTE, defined as the presence of asymptomatic deep vein thrombosis (DVT) determined by mandatory end-of-study (Day 21) bilateral lower limb venography, as adjudicated by the Adjudication Committee/Venography (AC/V), or the occurrence of a VTE event [symptomatic DVT, as adjudicated by the AC/V, or pulmonary embolism, as adjudicated by the Adjudication Committee/Venous Thromboembolic Event (AC/VTE)], during the course of study treatment. Statistical analysis of the primary endpoint will be performed with the Mantel-Haenszel statistic stratified by investigator site. The testing rule will be one-sided to detect greater patient response to TTP889 and alpha will be set at 0.05. Significance of potential covariates will be examined as ad-hoc analyses using the Mantel-Haenszel statistic (potentially the non-parametric extension to avoid power loss due to sparse strata). Only those patients who receive at least one dose of study medication and who have an adequate assessment for VTE by Day 21 will be included in the analysis of the primary efficacy endpoint. Patients having an adequate assessment of VTE by Day 21 is defined as those patients who underwent bilateral venography at the Day 21 Final Visit and who have a venogram that is judged to be adequate for evaluation by the AC/V, or patients with a d | — |
Countries
Czech Republic, Denmark, Sweden
Outcome results
None listed