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Thrombolytic Agent

CUSA-081 for Blood Clot (READY 1 Trial)

Phase 3
Waitlist Available
Research Sponsored by Chiesi Farmaceutici S.p.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (up to 120, 150, and 180 mins postdose)
Awards & highlights

READY 1 Trial Summary

This trial will test a new device to see if it is safe and effective at restoring central venous access devices (CVADs) in adults.

Eligible Conditions
  • Blood Clot
  • Catheter Blockage

READY 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (up to 120, 150, and 180 mins postdose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (up to 120, 150, and 180 mins postdose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage Of Participants With Treatment Success Following A Single Instillation Of Study Drug With A Dwell Time Up To 90 Mins
Secondary outcome measures
Percentage Of Participants With Treatment Success After Up To 2 Instillations Of Study Drug With A Total Dwell Time Up To 120, 150, And 180 Mins
Percentage Of Participants With Treatment Success Following A Single Instillation Of Study Drug With A Total Dwell Time Up To 30 And 60 Mins
Rate Of Recurrent Catheter Dysfunction Within 30 Days Following Treatment With Study Drug

READY 1 Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: CUSA-081Experimental Treatment1 Intervention
Participants will receive 1 or 2 doses of CUSA-081, 0.7 milligrams (mg) (0.4 units) per 2 milliliter (mL) directly into the catheter lumen. Participants will receive the first dose at minute (min) 0, and the second dose, if needed, at min 90.
Group II: AlteplaseActive Control1 Intervention
Participants will receive 1 or 2 doses of alteplase, 2 mg/mL, directly into the catheter lumen. Participants will receive the first dose at min 0, and the second dose, if needed, at min 90.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive 1 or 2 doses of placebo (normal saline) directly into the catheter lumen. Participants will receive the first dose at min 0, and the second dose, if needed, at min 90.

Find a Location

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor
198 Previous Clinical Trials
311,452 Total Patients Enrolled

Frequently Asked Questions

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

What is the federal government's position on CUSA-081?

"CUSA-081 has received a safety score of 3. This is because it has progressed to Phase 3 trials, meaning that there is both efficacy and safety data supporting its use."

Answered by AI

Have there been other scientific investigations that have utilized CUSA-081?

"CUSA-081 was first trialled in 2016 by the Department of Cardiology at Sahlgrenska University Hospital. As of now, there have been 18346 completed studies with 23 active trials taking place. A large number these clinical studies are based in Toledo, Ohio."

Answered by AI

What are the primary medical indications for CUSA-081?

"CUSA-081 can be used to efficiently treat thrombosis, cardiovascular mortality, and congestive heart failure (chf)."

Answered by AI

Are there different research facilities participating in this trial throughout the US?

"To make things more convenient for participants, the 30 sites for this study are located in or near major cities like Toledo, Lynchburg, and Honolulu. Selecting the clinic nearest you can help reduce travel time and related expenses."

Answered by AI

Are we still able to receive new participants for this research project?

"Yes, according to the latest information from clinicaltrials.gov, this trial is still looking for patients. It was first posted on February 12th 2020 and last updated March 29th 2022. The study requires 800 participants across 30 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Chiesi Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality
2020. "Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03594175.
~89 spots leftby Apr 2025
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