Comparing ticagrelor to standard dual antiplatelet therapy after heart procedures

A Single-center, Randomized, 6-month, Non-inferiority Study to Compare the Safety and Efficacy of TICAgreLor mONotherapy Versus Dual Antiplatelet Therapy in Chronic Coronary Syndrome Patients Post Percutaneous Coronary IntErvention (TICALONE)

This study is testing if taking ticagrelor alone is better than the usual combination of aspirin and clopidogrel for heart patients after a procedure to see if it helps prevent serious heart problems.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5400 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Shiraz University of Medical Sciences (Academic / other)
• Locations: 2 sites (Shiraz, Fars and 1 other locations)
• Trial ID: NCT06509893 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of ticagrelor monotherapy compared to standard dual antiplatelet therapy (DAPT) with aspirin and clopidogrel in patients undergoing percutaneous coronary intervention (PCI) for chronic coronary syndrome. Patients will be randomly assigned to receive either ticagrelor or the conventional DAPT for six months following their procedure. The primary focus is to assess the occurrence of major adverse cardiovascular events (MACE) within this period. The study is conducted at a single center, with careful monitoring of patient outcomes through a registry.

Who should consider this trial

Good fit: Ideal candidates include adults over 20 years old undergoing PCI with a drug-eluting stent for chronic coronary syndrome.

Not a fit: Patients with contraindications to the study medications or those requiring anticoagulant therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective antiplatelet therapy option for patients after PCI, potentially reducing the risk of major cardiovascular events.

How similar studies have performed: Previous studies have shown promising results with ticagrelor in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Male or female above 20 years of age undergoing PCI with a drug-eluting stent for chronic coronary syndrome
* The patient has provided written informed consent as approved by the ethics committee of the Shiraz University of Medical Sciences.

Exclusion Criteria:

* Contraindication to aspirin, clopidogrel, ticagrelor, or any other reason that study drug should not be administered (including hypersensitivity, moderate or severe liver disease, active bleeding, and major surgery within 30 days)
* Atrial fibrillation or other indication for oral anticoagulant therapy.
* Concomitant oral or IV therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices (cyclosporine, and quinidine), or strong CYP3A inducers ( rifampin, rifampicin, phenytoin, and carbamazepine)
* Females of child-bearing age unless negative pregnancy test at screening and willing to use effective contraception for the duration of trial
* Females who are breastfeeding at the time of enrolment.
* Unsuccessful PCI or PCI without optimal stent placement; this decision is made by the supervising interventional cardiologist.
* patients with anatomical SYNTAX score ≥23 prior to PCI
* Patients with planned surgical intervention to treat any cardiac or non-cardiac condition.
* Previous PCI in the last 6 months.
* Current (same hospitalization) or previous (within 12 months) acute coronary syndrome.
* History of definite stent thrombosis.
* Concomitant cardiac valve disease requiring invasive therapy.
* Acute heart failure.
* Active myocarditis.
* Cardiomyopathy.
* Patient in hemodialysis.
* History of stroke or transient ischemic cerebrovascular accident.
* History of intracranial hemorrhage or other intracranial pathology associated with increased bleeding risk.
* Hemoglobin \<10 g/dL
* Peptic ulceration documented by endoscopy within the last 3 months unless healing proven by repeat endoscopy.
* Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor.
* Participation in another trial with an investigational drug or device.
* Assessment that the subject is not likely to comply with the study procedures or have complete follow-up.
* Known drug or alcohol dependence within the past 12 months as judged by the investigator.

Where this trial is running

Shiraz, Fars and 1 other locations

• Cardiology Ward Shiraz University of Medical Sciences — Shiraz, Fars, Iran (Recruiting)
• professor Kojuroi cardiology clinic — Shiraz, Iran (Recruiting)

Study contacts

• Study coordinator: javad UOM Kojuri, MD.MS

Conditions Coronary Artery Disease; Percutaneous coronary intervention; dual antiplatelet therapy; clopidogrel; ticagrelor; MACE