Ticagrelor vs. Clopidogrel in Post PCI Patients

NCT05858918 | Completed DMC

• 1 other identifier: IR.SUMS.MED.REC.1401.351
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

Brief Summary

Elective PCI were included in the study. Patients were randomized into two different groups. One group took ASA 80 mg once daily and clopidogrel 75 mg once a day, and the other one took ASA 80 mg once a day and ticagrelor 90 mg twice a day. After six months of close follow-up, patients were asked to give a score to their dyspnea and asked about the major advance cardiovascular events ( MACE)

Conditions

Stable Chronic Angina

Keywords

Percutaneous coronary intervention; dual antiplatelet therapy; major adverse cardiovascular event; P2Y12 inhibitor; ticagrelor; clopidogrel

Outcome Measures

Primary Outcomes (2)

• dyspnoea

  feeling discomfort with respiration, based on 10 grade Likert grade ( minimum 0 and maximum 10, higher worse)

  6 months

• Number of patients with major adverse cardiovascular events

  post angioplasty and stenting patients who developed major events, acute coronary syndrome (ACS), stroke, revascularization, hospitalization due to heart failure, and cardiac death

  6 months

Secondary Outcomes (2)

• Number of patients with bleeding

  6 months

• PND

  6 months

Study Arms (2)

clopidogrel

ACTIVE COMPARATOR

patient post elective angioplasty and stenting receiving aspirin 80 mg and clopidogrel 75 mg PO daily

Drug: Clopidogrel

ticagrelor

ACTIVE COMPARATOR

patient post elective angioplasty and stenting receiving aspirin 80 mg and ticagrelor 90 mg PO twice daily

Drug: Ticagrelor

Interventions

Clopidogrel DRUG

Treatment with dual antiplatelet drug,aspirin 80 mg PO daily with clopidogrel 75 mg PO daily

clopidogrel

Ticagrelor DRUG

Treatment with dual antiplatelet drug,aspirin 80 mg PO daily with ticagrelor 90 mg PO twice daily

ticagrelor

Eligibility Criteria

• Age: 50 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experiencing elective percutaneous coronary intervention (PCI).

You may not qualify if:

• Patients diagnosed with hypersensitivity to either ticagrelor or clopidogrel
• Active pathological bleeding
• Patients who consumed anticoagulants in the course of their medical therapy

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Professor Kojuri Cardiology Clinic

Shiraz, 7134814336, Iran

Location

Related Publications (1)

• Mehdizadeh Parizi M, Golchin Vafa R, Ahmadi A, Heydarzade R, Sadeghi M, Khademolhossseini A, Amiri F, Khoshnood Mansorkhani S, Tavan A, Hosseini N, Montaseri M, Hosseini SA, Kojuri J. Comparison of Ticagrelor and Clopidogrel in Elective Coronary Stenting: A Double Blind Randomized Clinical Trial. J Interv Cardiol. 2023 Dec 26;2023:5544440. doi: 10.1155/2023/5544440. eCollection 2023.

  PMID: 38170033 DERIVED

MeSH Terms

Conditions

Angina, Stable

Interventions

Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: comparing two antiplatelet drugs , head to head, randomized

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: October 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)