SR34006 Compared to Placebo in Patients Who Have Complete... | NCT00071279

The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Oct 16, 2003

First Submission Date that Met QC Criteria

Oct 17, 2003

First Posted Date

Oct 20, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2011

Last Update Posted Date

Apr 6, 2011Estimated

Description Module

Brief Summary

Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.

In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.

Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,215Actual

Name	Type	Description	Arm Group Labels	Other Names
SR34006 (idraparinux sodium) Injection	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptomatic recurrent PE/DVT during the 6-month study treatment period.

Secondary Outcomes

Measure	Description	Time Frame
Major bleeding during the 6-month study treatment period.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months
Written informed consent

Exclusion Criteria:

Legal age limitations (country specific)
Indication for anticoagulation other than PE or DVT
Creatinine clearance (CLcr) <10 mL/min, severe hepatic disease, or bacterial endocarditis
Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT study within the prior 30 days
Life expectancy <3 months
Patients in whom anticoagulation treatment for their index PE or DVT should be continued beyond 6 months
Active bleeding or high risk for bleeding
Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure > 110 mm Hg
Pregnancy, or childbearing potential without proper contraceptive measures, women who are breastfeeding.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bay Pines VA Medical Center		Bay Pines	Florida		United States
Pulmonary Associates of Brandon

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17855671	Derived	van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Extended prophylaxis of venous thromboembolism with idraparinux. N Engl J Med. 2007 Sep 13;357(11):1105-12. doi: 10.1056/NEJMoa067703.

ID	Term
D011655	Pulmonary Embolism
D020246	Venous Thrombosis

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013927	Thrombosis

ID	Term
C479958	idraparinux
D007267	Injections

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics