Effect of Diabetes and Hepatic Enzymes Mutation on Clopidogrel VS Ticagrelor Activity in Myocardial Infarction (MI) Patients Undergoing Primary Percutaneous Coronary Intervention (PCI)

NCT03613857 | Completed DMC FDA Drug

• 1 other identifier: pharmacology department CU
• Study Type: observational
• Target: 1,022
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the combined effect of diabetes mellitus and cyp2c19 polymorphism on platelet aggregation inhibitory activity of the highest traditionally used loading dose 600 mg clopidogrel and ticagrelor 180 mg loading dose will be compared in acute coronary syndrome (ACS) patients undergoing PCI.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (4)

• Acute and sub-acute stent thrombosis

  stent thrombosis 24 hr to one month after stent implantation

  up to one month after stent implantation

• Cardiovascular death

  Death with cardiovascular etiology

  three to six months after PCI

• Non-fatal myocardial infarction

  Survival after hospital admission due to ST elevation or non-ST elevation myocardial infarction

  three to six months after PCI

• Ischemic or hemorrhagic stroke

  three to six monthes after PCI

Study Arms (2)

Clopidogrel group

Anterior myocardial infarction patients undergoing percutaneous coronary intervention take loading dose 600 mg oral clopidogrel (plavix) tablets before the procedure.

Drug: Clopidogrel

Ticagrelor group

Anterior myocardial infarction patients undergoing percutaneous coronary intervention take loading dose180 mg oral ticagrelor (brilique) tablets before the procedure.

Drug: Ticagrelor 90mg

Interventions

Clopidogrel DRUG

8 tablets 75 mg clopidogrel loading dose before PCI

Also known as: plavix

Clopidogrel group

Ticagrelor 90mg DRUG

2 tablets 90 mg brilique before PCI

Also known as: brilique

Ticagrelor group

Eligibility Criteria

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

Study Population

Diabetic and non-diabetic patients with ST-elevation elevation and non-ST elevation myocardial infarction undergoing PCI.

You may qualify if:

• Diabetic and non-diabetic patients with anterior ST-elevation and non-ST elevation myocardial infarction undergoing PCI.

You may not qualify if:

• Patients who are with a family or personal history of bleeding.
• Patients with platelet count less than 100 x 103/ul.
• Patients with known hypersensitivity to clopidogrel.
• Patients with serious bleeding tendency, history of intracranial hemorrhage, signs of active bleeding, uncontrolled hypertension.
• Patients with severe liver disorders

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of pharmacy Cairo university

Cairo, 01234567, Egypt

Location

Related Publications (1)

• Mohareb MW, AbdElghany M, Zaki HF, El-Abhar HS. Diabetes and CYP2C19 Polymorphism Synergistically Impair the Antiplatelet Activity of Clopidogrel Compared With Ticagrelor in Percutaneous Coronary Intervention-treated Acute Coronary Syndrome Patients. J Cardiovasc Pharmacol. 2020 Oct;76(4):478-488. doi: 10.1097/FJC.0000000000000881.

  PMID: 32675750 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher at clinical pharmacology department cairo university, principal investigator

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 3, 2018
• Study Start: April 15, 2017
• Primary Completion: July 28, 2018
• Study Completion: July 28, 2018
• Last Updated: January 14, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)