Individualized and Combined Effects of Smoking and Diabetes on the Antiplatelet Activity in Patients Undergoing Primary Percutaneous Coronary InterventionNCT05911659
Individualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI
An observational study of Individualized and Combined Effects of Smoking and Diabetes on the Antiplatelet Activity in Patients Undergoing Primary Percutaneous Coronary Intervention, run by Mina Wageh Mohareb at 1 site in Egypt.
Trial summary
Background:Diabetes and smoking are common factors found to increase platelet reactivity in patients undergoing primary PCI. Objective: Compare the individualized and combined effects of smoking and diabetes on the antiplatelet activity in patients undergoing primary PCI. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Individualized and Combined Effects of Smoking and Diabetes on the Antiplatelet Activity in Patients Undergoing Primary Percutaneous Coronary Intervention
- What is being tested?
- Ticagrelor
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 15 Jun 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with ACS undergoing PCI
Who may be able to join
- Acute coronary syndrome (ACS) undergoing PCI
Who cannot join
- Patients who had a history of severe bleeding, serious bleeding tendency, history of intracranial hemorrhage, signs of active bleeding, thrombocytopenia, uncontrolled hypertension, hypersensitivity to the used drugs (clopidogrel or ticagrelor), concomitant use of strong CYP inducers or inhibitors, and/or severe liver disorders were excluded from the study.
- Patients with previous history of coronary artery disease, previous PCI or patients administering other antiplatelets were excluded from the current study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine of girls, Cardiology department, Al-Azhar University in Cairo
Cairo
Nasima M Elkenany, Ph.D.
About this study
Official title: Ndividualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI
Background:Diabetes and smoking are common factors found to increase platelet reactivity in patients undergoing primary PCI. Objective: Compare the individualized and combined effects of smoking and diabetes on the antiplatelet activity in patients undergoing primary PCI. Methods: sixty patients were recruited in this study. Patients were allocated to one of four groups according to the diabetes and smoking status. Non smokers- non diabetic patients, smokers non diabetic patients, non smokers diabetic patients, and smokers diabetic patients, 15 patients in each group. All patients received 180 mg ticagrelor before PCI. Platelet reactivity index(PRI) and maximum platelet aggregation were measured 24 hours after ticagrelor loading dose for each patient as indicators for antiplatelet efficacy. PRI and/or MPA values > 50% were defined as high platelet reactivity.
- Being tested
- Ticagrelor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Primary percutaneous coronary intervention (PCI)
Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI
| Study group | Role | What they receive |
|---|---|---|
| Non smokers- non diabetic patients | Not described Receives: Drug: Ticagrelor | |
| smokers non diabetic patients | Not described Receives: Drug: Ticagrelor | |
| non smokers diabetic patients | Not described Receives: Drug: Ticagrelor | |
| smokers diabetic patients | Not described Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Reactivity Index and maximum platelet aggregation
Platelet aggregation indicator
Measured: 24 hours after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 May 2023
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Individualized and Combined Effects of Smoking and Diabetes on the Antiplatelet Activity in Patients Undergoing Primary Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Mina Wageh Mohareb
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor-investigator, Mina Wageh Mohareb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911659
- Sponsor's protocol ID
- Al-Azhar University
- Status last verified
- Jun 2023
- First submitted
- 10 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ndividualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI
- ClinicalTrials.gov ID
- NCT05911659
- Acronym / sponsor ID
- Al-Azhar University
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mina Wageh MoharebUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:Diabetes and smoking are common factors found to increase platelet reactivity in patients undergoing primary PCI. Objective: Compare the individualized and combined effects of smoking and diabetes on the antiplatelet activity in patients undergoing primary PCI. Methods: sixty patients were recruited in this study. Patients were allocated to one of four groups according to the diabetes and smoking status. Non smokers- non diabetic patients, smokers non diabetic patients, non smokers diabetic patients, and smokers diabetic patients, 15 patients in each group. All patients received 180 mg ticagrelor before PCI. Platelet reactivity index(PRI) and maximum platelet aggregation were measured 24 hours after ticagrelor loading dose for each patient as indicators for antiplatelet efficacy. PRI and/or MPA values > 50% were defined as high platelet reactivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non smokers- non diabetic patients | – | Drug: Ticagrelor |
| smokers non diabetic patients | – | Drug: Ticagrelor |
| non smokers diabetic patients | – | Drug: Ticagrelor |
| smokers diabetic patients | – | Drug: Ticagrelor |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with ACS undergoing PCI
Key inclusion criteria (1 listed)
- Acute coronary syndrome (ACS) undergoing PCI
Key exclusion criteria (2 listed)
- Patients who had a history of severe bleeding, serious bleeding tendency, history of intracranial hemorrhage, signs of active bleeding, thrombocytopenia, uncontrolled hypertension, hypersensitivity to the used drugs (clopidogrel or ticagrelor), concomitant use of strong CYP inducers or inhibitors, and/or severe liver disorders were excluded from the study.
- Patients with previous history of coronary artery disease, previous PCI or patients administering other antiplatelets were excluded from the current study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: Primary percutaneous coronary intervention (PCI)Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI | Drug | Non smokers- non diabetic patients, non smokers diabetic patients, smokers diabetic patients, smokers non diabetic patients |
Primary outcome
Platelet Reactivity Index and maximum platelet aggregation
Time frame: 24 hours after PCI
Platelet aggregation indicator
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Individualized and Combined Effects of Smoking and Diabetes on the Antiplatelet Activity in Patients Undergoing Primary Percutaneous Coronary Intervention, run by Mina Wageh Mohareb at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasima M El-Kenany, Ph.D (01007844927 ext. +20, mina.moharebmedicinewolters@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Reactivity Index and maximum platelet aggregation (time frame: 24 hours after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.