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PROTamine Application in patients underGOing tRAnScatheter aortic valve replacement (PROTAGORAS)
EU CTIS ID: 2024-512024-10-01
What this study is testing
To assess the clinical benefit with respect to major bleeding and major ischemic events of post-procedural heparin reversal with protamine after transcatheter aortic valve replacement.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Age ≥55 years
- • Severe aortic stenosis
- • Scheduled for transfemoral TAVR
- • Willing to participate, able to understand and to consent, signed informed consent
You likely can't join if
- • Presence of mechanical heart valve
- • Pregnant women and women of childbearing potential
- • Prior allergic reaction to protamine or increased anaphylactic risk according to the investigator’s discretion
- • Prior heparin-induced thrombocytopenia
- • Known heparin allergy
- • Percutaneous coronary intervention within 4 weeks prior to TAVR
See the full eligibility criteria
- • Age ≥55 years
- • Severe aortic stenosis
- • Scheduled for transfemoral TAVR
- • Willing to participate, able to understand and to consent, signed informed consent
- • Presence of mechanical heart valve
- • Pregnant women and women of childbearing potential
- • Prior allergic reaction to protamine or increased anaphylactic risk according to the investigator’s discretion
- • Prior heparin-induced thrombocytopenia
- • Known heparin allergy
- • Percutaneous coronary intervention within 4 weeks prior to TAVR
- • Severe TAVR procedure complications (Annulus rupture, aortic dissection, coronary oc-clusion, cardiogenic shock, conversion to open surgery, pericardial tamponade, stroke, valve prosthesis dislocation, mechanical resuscitation not related to bleeding, any other acute TAVR procedure complication considered severe or life threatening by the investigator)
- • Patients on direct oral anticoagulants if not paused on the day of TAVR procedure
- • Patients on vitamin K antagonists if INR > 1.8 before TAVR procedure (last measure-ment within three days prior procedure)
- • Subjects participating in another clinical trial with an investigational new drug or not commercially available and approved devices
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.