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Anticoagulant

Tinzaparin + Rivaroxaban for Post-Thrombotic Syndrome (TILE Trial)

Q: How many individuals are being observed in this research endeavor?

Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was first published on November 15th 2021, is actively seeking participants. 60 individuals are needed to be recruited from 4 distinct medical sites.

Q: Is this experiment the pioneering effort of its kind?

Research into tinzaparin was initiated in 2015 under the sponsorship of Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma. After a successful Phase 3 trial involving 2180 participants, it has since been approved as a drug and is currently being studied at 63 distinct locations across 37 countries.

Q: Could you elucidate the potential risks associated with tinzaparin usage?

Tinzaparin is deemed safe by our team at Power, and thus awarded a score of 3. This evaluation was made due to its Phase 4 trial status - an indication that it has been authorized for use in healthcare settings.

Q: Are there any openings presently available for this research project?

According to information posted on clinicaltrials.gov, this medical trial is presently open for recruitment and first went live on November 15th 2021 with the last update occurring September 20th 2022.

Q: For what medical conditions is tinzaparin typically prescribed?

Tinzaparin is typically used to treat chronic coronary artery disease, yet it may also be employed to address certain complications related to venous thromboembolism and general surgery, such as deep vein thrombosis.

Q: What is the central aim of this clinical investigation?

The primary end goal of this study, as outlined by its sponsor LEO Pharma, is to measure Post-Treatment Symptoms (PTS) at 6 months post randomization. Additionally, secondary objectives include assessing patient satisfaction with treatment via a 7 point visual analog scale questionnaire and calculating Villalta score at 10 days in order to evaluate the severity of PTS (mild, moderate or severe).

Phase 4

Waitlist Available

Led By Jean-Philippe Galanaud, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with objectively confirmed acute (i.e. onset of symptoms <10 days) symptomatic iliac or common femoral DVT (DVT diagnosis will be made with a Compression Ultrasound (CUS) according to standardized consensus criteria)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three time points: at 3 weeks and at 6 months post randomization

Awards & highlights

TILE Trial Summary

This trial will compare two different treatments for preventing post-thrombotic syndrome in patients who have had deep vein thrombosis. One treatment is LMWH, and the other is DOAC.

Who is the study for?

This trial is for adults with a recent diagnosis of iliac or common femoral deep vein thrombosis confirmed by ultrasound. It's not for pregnant or breastfeeding individuals, those under 18, people with impaired kidney function, active cancer, certain drug sensitivities including lactose and sulphite, liver disease with coagulopathy, extreme body weights, or anyone on conflicting medications.Check my eligibility

What is being tested?

The TILE study compares two treatments to prevent post-thrombotic syndrome in patients with deep vein thrombosis: extended use of tinzaparin (a type of heparin) versus rivaroxaban (an oral anticoagulant). Participants are randomly assigned to one treatment group in this open-label trial where outcomes are assessed blindly.See study design

What are the potential side effects?

Potential side effects include bleeding risks due to the blood-thinning nature of both tinzaparin and rivaroxaban. There may also be allergic reactions to the drugs' components. Kidney function might be affected by rivaroxaban in susceptible individuals.

TILE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a recent blood clot in my leg confirmed by an ultrasound.

TILE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three time points: at 3 weeks and at 6 months post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three time points: at 3 weeks and at 6 months post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and three time points: at 3 weeks and at 6 months post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Main feasibility

PTS at 6 months

Secondary outcome measures

DVT-related leg pain

Global Improvement

PTS severity

+6 more

Other outcome measures

Health Services Research Issues

TILE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TinzaparinExperimental Treatment1 Intervention

initial 3-week lead-in course of low molecular weight heparin (tinzaparin 175 units/Kg sc daily) followed by a direct oral anticoagulant (rivaroxaban 20mg po daily) for at least 3 months

Group II: RivaroxabanActive Control1 Intervention

Direct oral anticoagulant only (rivaroxaban 15mg po BID for 3 weeks followed by rivaroxaban 20mg po daily ) for at least 3 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

tinzaparin

2005

Completed Phase 4

~400

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,433 Total Patients Enrolled

LEO PharmaIndustry Sponsor

268 Previous Clinical Trials

188,442 Total Patients Enrolled

Sunnybrook Research InstituteOTHER

31 Previous Clinical Trials

215,810 Total Patients Enrolled

Media Library

Rivaroxaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04794569 — Phase 4

Post-Thrombotic Syndrome Research Study Groups: Rivaroxaban, Tinzaparin

Post-Thrombotic Syndrome Clinical Trial 2023: Rivaroxaban Highlights & Side Effects. Trial Name: NCT04794569 — Phase 4

Rivaroxaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04794569 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being observed in this research endeavor?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was first published on November 15th 2021, is actively seeking participants. 60 individuals are needed to be recruited from 4 distinct medical sites."

Answered by AI

Is this experiment the pioneering effort of its kind?

"Research into tinzaparin was initiated in 2015 under the sponsorship of Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma. After a successful Phase 3 trial involving 2180 participants, it has since been approved as a drug and is currently being studied at 63 distinct locations across 37 countries."

Answered by AI

Could you elucidate the potential risks associated with tinzaparin usage?

"Tinzaparin is deemed safe by our team at Power, and thus awarded a score of 3. This evaluation was made due to its Phase 4 trial status - an indication that it has been authorized for use in healthcare settings."

Answered by AI

Are there any openings presently available for this research project?

"According to information posted on clinicaltrials.gov, this medical trial is presently open for recruitment and first went live on November 15th 2021 with the last update occurring September 20th 2022."

Answered by AI

For what medical conditions is tinzaparin typically prescribed?

"Tinzaparin is typically used to treat chronic coronary artery disease, yet it may also be employed to address certain complications related to venous thromboembolism and general surgery, such as deep vein thrombosis."

Answered by AI

What is the central aim of this clinical investigation?

"The primary end goal of this study, as outlined by its sponsor LEO Pharma, is to measure Post-Treatment Symptoms (PTS) at 6 months post randomization. Additionally, secondary objectives include assessing patient satisfaction with treatment via a 7 point visual analog scale questionnaire and calculating Villalta score at 10 days in order to evaluate the severity of PTS (mild, moderate or severe)."

Answered by AI