Ticagrelore Alone Post PCI

NCT06509893 | Recruiting Phase 4 DMC

• 1 other identifier: IR.SUMS.MED.REC.1403.150
• Study Type: interventional
• Target: 5,400
• Locations: 1 country
• Sites: 2

Brief Summary

After PCI for CCS patients, single center double blind randomization will be done and patients will receive aspirin 80 mg and clopidogrel 75 mg versus 90 mg two times daily of ticagrelor, for 6 months and MACE will be followed in registry of professor Kojuri cardiology clinic

Conditions

Coronary Artery Disease

Keywords

Percutaneous coronary intervention; dual antiplatelet therapy; clopidogrel; ticagrelor; MACE

Outcome Measures

Primary Outcomes (3)

• stent thrombosis

  Post PCI till 6 months any confirmed or suspected episodes of stent thrombosis based on ARCH definition

  6 months

• Major adverse cardiovascular events

  Any episodes of myocardial infarction, acute coronary syndrome, revascularization, hospital admission and major vascular events will be recorded

  6 months

• Bleeding

  any major or minor bleeding based on HASBLED criteria

  6 months

Secondary Outcomes (1)

• Treatment related adverse reactions

  6 months

Study Arms (2)

Clopidogrel and aspirin

ACTIVE COMPARATOR

Patients post PCI randomized to Aspirin 80 mg and clopidogrel 75 mg daily

Drug: aspirin 80 mg and clopidogrel 75 mg daily

ticagrelor

EXPERIMENTAL

Patients post PCI randomized to Ticagrelor 90 mg PO two times daily

Drug: Ticagrelor 90 MG

Interventions

aspirin 80 mg and clopidogrel 75 mg daily DRUG

post PCI patients received these two drugs as dual antiplatelet regimen

Clopidogrel and aspirin

Ticagrelor 90 MG DRUG

Post PCI patients receive Ticagrelor 90 mg two times daily as single potent antiplatelet

ticagrelor

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (2)

Cardiology Ward Shiraz University of Medical Sciences

Shiraz, Fars, 51318, Iran

RECRUITING

professor Kojuroi cardiology clinic

Shiraz, 7134814336, Iran

RECRUITING

Related Publications (1)

• Mirhosseini SA, Akbari M, Aldavood D, Zarifkar H, Attar A, Kojuri J. Rationale and design of randomized non-inferiority clinical trial to compare the safety and efficacy of ticagrelor monotherapy with dual antiplatelet therapy in chronic coronary syndrome patients post percutaneous coronary intervention (TICALONE-TAHA10 Protocol). PLoS One. 2025 Jul 16;20(7):e0325663. doi: 10.1371/journal.pone.0325663. eCollection 2025.

  PMID: 40668853 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

javad UOM Kojuri, MD.MS

CONTACT

09171115083; kojurij@yahoo.com

javad UOM Kojuri, MD.MS.

CONTACT

09171115083; kojurij@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)