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CompletedNCT03613857Updated Jan 14, 2019

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

An observational study in Myocardial Infarction, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-14.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,022
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Study subjects Inclusion criteria Diabetic patients (well-controlled type 2 diabetes mellitus) and non-diabetic patients with anterior ST-elevation and non-st elevation myocardial infarction undergoing PCI.

Exclusion criteria 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 or ticagrelor. Patients with serious bleeding tendency, history of intracranial hemorrhage, a sign of active bleeding, uncontrolled hypertension.

Patients with severe liver disorders

Methods The study will be conducted in the cardiac intensive care unit at Assiut educational hospital of cardiovascular diseases.

  • diabetic and non-diabetic patients with ST-elevation and non-ST elevation myocardial infarction undergoing PCI will be enrolled in this study.
  • At baseline, all patients will undergo full clinical examination and laboratory diagnostic tests. Current and previous medical history and medication history will be thoroughly investigated.

Recruited patients will be classified into two groups. One group will receive 600 mg loading dose clopidogrel before PCI and 75 mg daily maintenance dose. The other group of patients will receive 180 mg loading dose ticagrelor before PCI and 90 mg twice daily maintenance dose.

A blood sample of will be withdrawn from each patient to undergo genotypic testing using Real Time polymerase chain reaction (PCR) to detect polymorphism in the cyp2c19 enzyme.

  • Clopidogrel and ticagrelor antiplatelet activity will be assessed by estimating the maximum platelet aggregation (MPA) using light transmittance platelet aggregometry and platelet reactivity index (PRI) using whole-blood vasodilator-stimulated phosphoprotein (VASP) measured by quantitative flow cytometry.
  • All patients will be followed-up for at least three to six months month by clinic visits and phone calls to detect acute and subacute stent thrombosis, acute cardiac events, revascularization and cardiovascular death after PCI.

Study endpoints Acute stent thrombosis 24 hours after PCI and sub-acute stent thrombosis within 30 days after PCI, cardiovascular death, recurrent acute cardiac events, recurrent unstable anginal pain and hospitalization for cardiovascular diseases.

02

Conditions studied

  • Myocardial Infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 1,022 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,022 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • DrugClopidogrel

    8 tablets 75 mg clopidogrel loading dose before PCI

    Also known as: plavix

  • DrugTicagrelor 90mg

    2 tablets 90 mg brilique before PCI

    Also known as: brilique

06

What researchers measure

Primary outcomes

  1. Acute and sub-acute stent thrombosis

    stent thrombosis 24 hr to one month after stent implantation

    Time frame: up to one month after stent implantation

  2. Cardiovascular death

    Death with cardiovascular etiology

    Time frame: three to six months after PCI

  3. Non-fatal myocardial infarction

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

    Time frame: three to six months after PCI

  4. Ischemic or hemorrhagic stroke

    Time frame: three to six monthes after PCI

07

Study locations

1 site
  • Faculty of pharmacy Cairo university
    Cairo, 01234567, Egypt
08

References and documents

Publications

  • 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. PubMed 32675750 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03613857
Lead sponsor
Cairo University
Responsible party
Mina Wageh Mohareb (researcher at clinical pharmacology department cairo university, principal investigator, Cairo University) — Principal investigator
First posted
Aug 3, 2018
Start date
Apr 15, 2017
Primary completion
Jul 28, 2018
Completion
Jul 28, 2018
Last update
Jan 14, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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