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

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ClinicalTrials.gov Identifier: NCT03613857
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Mina Wageh Mohareb, Cairo University

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.

Condition or disease Intervention/treatment
Myocardial Infarction Drug: Clopidogrel Drug: Ticagrelor 90mg

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A blood sample of will be withdrawn from each patient to undergo genotypic testing using Real Time polymerase chain reaction (PCR) to detect polymorphism in the cyp2c19 enzyme.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


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Study Type : Observational [Patient Registry]
Actual Enrollment : 1022 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Combined Effect of Diabetes and cyp2c19 Polymorphism on Clopidogrel VS Ticagrelor Antiplatelet Activity in Patients of Anterior ST Elevation Myocardial Infarction Undergoing Primary PCI
Actual Study Start Date : April 15, 2017
Actual Primary Completion Date : July 28, 2018
Actual Study Completion Date : July 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort Intervention/treatment
Clopidogrel group
Anterior myocardial infarction patients undergoing percutaneous coronary intervention take loading dose 600 mg oral clopidogrel (plavix) tablets before the procedure.
Drug: Clopidogrel
8 tablets 75 mg clopidogrel loading dose before PCI
Other Name: plavix

Ticagrelor group
Anterior myocardial infarction patients undergoing percutaneous coronary intervention take loading dose180 mg oral ticagrelor (brilique) tablets before the procedure.
Drug: Ticagrelor 90mg
2 tablets 90 mg brilique before PCI
Other Name: brilique




Primary Outcome Measures :
  1. Acute and sub-acute stent thrombosis [ Time Frame: up to one month after stent implantation ]
    stent thrombosis 24 hr to one month after stent implantation

  2. Cardiovascular death [ Time Frame: three to six months after PCI ]
    Death with cardiovascular etiology

  3. Non-fatal myocardial infarction [ Time Frame: three to six months after PCI ]
    Survival after hospital admission due to ST elevation or non-ST elevation myocardial infarction

  4. Ischemic or hemorrhagic stroke [ Time Frame: three to six monthes after PCI ]

Biospecimen Retention:   Samples With DNA
Blood samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

-Diabetic 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.
  • Patients with serious bleeding tendency, history of intracranial hemorrhage, signs of active bleeding, uncontrolled hypertension.
  • Patients with severe liver disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613857


Locations
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Egypt
Faculty of pharmacy Cairo university
Cairo, Egypt, 01234567
Sponsors and Collaborators
Cairo University

Additional Information:

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Responsible Party: Mina Wageh Mohareb, researcher at clinical pharmacology department cairo university, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03613857     History of Changes
Other Study ID Numbers: pharmacology department CU
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Clopidogrel
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs