Using an algorithm to tailor antiplatelet therapy after heart procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of a score-based algorithm to determine the duration of dual antiplatelet therapy (DAPT) for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. It compares outcomes between patients receiving algorithm-guided DAPT and those on standard DAPT without risk scores. The study aims to provide direct evidence on the benefits of using risk scores in clinical practice. A total of 2788 patients aged 18 and older will be randomized into two groups to assess the efficacy and safety of this approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. PCI with drug eluting stent (DES) implantation
2. Age ≥18 years
3. Ability to sign informed consent before any study-specific procedure

Exclusion Criteria:

1. Planned staged PCI (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop an indication for percutaneous valve intervention can undergo treatment 30 days after full coronary revascularization)
2. Indication for oral anticoagulation
3. Peri-procedural complication which affects DAPT regimen based on the operator's opinion (e.g. untreated flow-limiting angiographic complication, intraprocedural stent thrombosis, persistent vessel occlusion/no-reflow at the end of the procedure, major side-branch occlusion, puncture-site related or other relevant bleeding)
4. Treatment for stent thrombosis at qualifying PCI or within 1 year prior to qualifying PCI
5. Active bleeding requiring medical attention at qualifying PCI
6. The presence of hemodynamic instability (persistent systolic blood pressure below 90mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices)
7. Life expectancy less than 1 year
8. Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile)
9. Planned surgery within the next 3 months
10. Contraindication or known allergy against aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel)
11. Participation in a drug trial

Where it's running

• University Clinical Center of the Republic of Srpska
  Banja Luka, Bosnia and Herzegovina Recruiting
• UOC Cardiologia San Giovanni Addolorata Hospital
  Roma, Italy Recruiting
• Kardiologie Spitalzentrum Biel
  Biel/Bienne, Canton of Bern, Switzerland Recruiting
• Department of Cardiology, Bern University Hospital
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Miklos Rohla, MD, PhD — Department of Cardiology, Bern University Hospital, Bern, Switzerland
• Study coordinator: Lorenz Räber, MD, PhD
• Email: Lorenz.raeber@insel.ch
• Phone: +41 31 632 09 29

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Aspirin 50 mg vs 100 mg with a P2Y12 inhibitor after PCI

  This trial tests whether a 50 mg daily aspirin dose, when used with a P2Y12 inhibitor after PCI, works as well as 100 mg with similar safety for people staying on DAPT for 12 months.

  Recruiting Jilin University · Changchun, Jilin · NCT07846462

• Long-term P2Y12 inhibitor monotherapy and blood clotting after angioplasty

  This trial will test whether specific P2Y12 drugs and reduced doses given alone keep platelet activity in a safe therapeutic range for people who completed initial dual antiplatelet therapy after PCI.

  Recruiting Phase 3 Cardiocentro Ticino · Lugano, Ch/ti · NCT07582835

• What affects bleeding control and how long you need to lie flat after femoral arterial sheath removal

  We will see if patient and procedure factors can predict how long ICU patients need compression and bed rest after femoral arterial sheath removal to prevent bleeding and hematoma.

  Recruiting National Taiwan University Hospital · Taipei · NCT07469397

• Doctors' and patients' preferences for PCI implantation devices

  This questionnaire tests what patients who have had PCI and the doctors who treat them prefer between drug-eluting stents and drug-coated balloons.

  Recruiting Xijing Hospital · Xi'an, Shannxi · NCT07378163

• How patients and doctors value different outcomes after coronary stent procedures

  This project asks patients who had a coronary stent (PCI) and the doctors who treat them to rate how important different possible outcomes are to see if their priorities match.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT07378137

• Flozins to prevent contrast-related kidney injury after coronary angiography or PCI

  This project tests whether taking a flozin (empagliflozin or dapagliflozin), short-term or long-term, lowers the chance of contrast-induced acute kidney injury in patients having coronary angiography or PCI.

  Recruiting Collegium Medicum w Bydgoszczy · Bydgoszcz · NCT07231939

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.