Superficial Thrombophlebitis (also known as superficial vein thrombosis) MedDRA version: 8.1 Level: LLT Classification code 10042557 Term: Superficial thrombophlebitis of leg
Conditions
Interventions
Trade Name: ARIXTRA
Product Name: ARIXTRA
Pharmaceutical Form: Injection*
INN or Proposed INN: Fondaparinux Sodium
CAS Number: 114870-03-0
Current Sponsor code: GSK576428
Concentration unit: mg milli
Sponsors
GlaxoSmithKline Research & Development Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the Fondaparinux Sodium Investigator’s Brochure. Subjects eligible for enrolment in the study must meet all the following criteria: • Hospitalised or non-hospitalised male or female patients 18 years of age or greater , • With acute symptomatic isolated ST of the lower limbs at least 5 cm long documented by standard CUS, • Able and willing to provide written informed consent. Acute ST is ST in which the delay between symptom onset and randomisation is less than three weeks. Isolated ST is ST without concomitant asymptomatic or symptomatic DVT and/or symptomatic PE. On CUS, ST will be defined as a subcutaneous non-compressible hypoechoic area in the course of an identified superficial vein (looking circular in cross sectional view, and quite rectangular in longitudinal view) of more than 5 cm in length [The STENOX Study Group, 2003] and more than 3 mm in maximum antero-posterior diameter under compression. The thrombosed vein will be named according to the anatomical nomenclature [Caggiati, 2006] and the UIP (Union Internationale de Phlébologie) consensus [Cavezzi, 2006; Coleridge, 2006]. In France, a subject will be eligible for inclusion in this study if either affiliated to or a beneficiary of a social security category. This is an additional inclusion criterion only applying to subjects enrolled in France. 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: Exclusion criteria related to disease characteristics at presentation: •ST following sclerotherapy or resulting as a complication of an intravenous line, •Palpable hard cord without any inflammation and, on CUS, with an antero-posterior diameter < 5 mm and uniformly hyperechoic (high probability of old ST), •Delay between symptom onset and randomisation greater than 21 days, •Delay between diagnosis by CUS and randomisation greater than 48 hours (exceptionally, if the delay between CUS and randomisation exceeds this time period, the patient may be randomised if eligibility is confirmed by repeat CUS), •Treatment of the current episode of ST with antithrombotic or anticoagulant therapy, including low-dose anticoagulation, for more than 48 hours prior to randomisation, •Treatment of the current episode of ST with oral NSAIDs for more than 72 hours prior to randomisation, •Treatment of the current episode of ST with aspirin at doses greater than 325 mg per day for more than 72 hours prior to randomisation, •ST within 3 cm from the sapheno-femoral junction, •Symptomatic or asymptomatic DVT on qualifying CUS, •Documented presence of symptomatic PE, •Requirement for ligation of the sapheno-femoral junction, thrombectomy or planned intervention for stripping of varicose veins during the study period, •History of documented ST occurring within the last 90 days, •History of documented DVT or PE within the last six months, •ST in patients with active cancer (i.e. treated for cancer within the last six months). Exclusion criteria related to concomitant medication: •Anticoagulant therapy required or likely to be required during the study period (e.g. planned surgery justifying pharmacological thromboprophylaxis), •Treatment with aspirin at a dose greater than 325 mg per day or oral NSAIDs (at any dose) required or likely to be required during the study period. •Exclusion criteria related to study treatments: •Known hypersensitivity to fondaparinux or its excipient, •Women of childbearing potential not using a reliable contraceptive method throughout the study period (a list of reliable contraceptive methods is provided in Section 11.3, Appendix 3),, •Pregnant or breast-feeding women during the study period. Exclusion criteria based on risk of bleeding: •Active, clinically significant bleeding, •Clinically significant bleeding within the past month, •Patient judged by the investigator to be at high risk of bleeding, •Major surgery within the previous three months, •Ophthalmic, spinal, and/or brain surgery within the previous twelve months, •Haemorrhagic stroke within the previous twelve months, •Severe head injury within the previous three months, •Documented congenital or acquired bleeding tendency/disorder(s), •Previous or active peptic ulcer disease, •Uncontrolled arterial hypertension (systolic blood pressure over 180 mm Hg or diastolic blood pressure over 110 mm Hg), •Treatment with more than one antiplatelet agent (e.g. clopidogrel, aspirin) at any dose, •Bacterial endocarditis, •Severe hepatic impairment, •Platelet count below 100?109/L, •Prothrombin time ratio below 50%. If the prothrombin time ratio is not available, than any of the following is an exclusion criterion: prothrombin level, INR or prothrombin time significantly outside the normal range for the local laboratory , such that it could lead to an increased bleeding risk for the patient in the investigator's judgment. •Calculated creatinine clearance < 30 mL/min, •Body weigh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate the efficacy of fondaparinux 2.5 mg once daily versus placebo with respect to the occurrence of the primary efficacy endpoint (symptomatic VTE events and/or death) from any cause up to Day 45 (end of treatment period) in patients with isolated ST of the lower limbs. The principal safety endpoint of the study is to evaluate fondaparinux 2.5 mg once daily versus placebo with respect to the occurrence of major bleeding and/or death up to Day 49 (end of treatment period plus four days) in patients with isolated ST of the lower limbs.;Secondary Objective: The secondary objective of the study is to demonstrate the efficacy of fondaparinux 2.5 mg once daily versus placebo with respect to the occurrence of symptomatic VTE events and/or death from any cause up to Day 75 (end of follow-up) in patients with isolated ST of the lower limbs The principal safety endpoint will also be evaluated up to Day 75. Other safety objectives of the study are to evaluate the overall safety of fondaparinux 2.5 mg once daily versus placebo with respect to symptomatic arterial thromboembolic events and other adverse events (AE).;Primary end point(s): The primary efficacy endpoint is VTE and/or death from any cause up to Day 45 (end of study treatment period). VTE is defined in this study as a composite of symptomatic PE, symptomatic DVT, symptomatic recurrence of ST or symptomatic extension of ST. | — |
Countries
Bulgaria, Czech Republic, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Spain, United Kingdom
Outcome results
None listed