Acute Coronary SyndromesNCT06878638
Nitrate - Clopidogrel - Acute Coronary Syndrome
An observational study of Acute Coronary Syndromes, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate whether intravenous nitrate given during non-ST-elevation myocardial infarction (non-STEMI) affects the platelet inhibition of clopidogrel. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndromes
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Apr 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: acute coronary syndrome patients
Who may be able to join
- diagnosed with non-STEMI
- Patients aged 18 to 75 years
- positive troponin levels,
- blood pressure above 120/70 mmHg
Who cannot join
- Hemodynamically unstable and requiring urgent intervention,
- ST elevation on electrocardiography, atrial fibrillation,
- recurrent angina,
- use of narcotic analgesics (e.g., morphine), nitrates and glycoprotein IIb/IIIa inhibitors during hospitalization,
- history of coronary artery bypass graft (CABG) surgery,
- active infection,
Show all 13Show fewer
- uncontrolled hypertension,
- diabetes, cerebrovascular accident, Use P2Y12 inhibitor, proton pump inhibitor, oral anticoagulant, statin, CYP enzyme-inducing or inhibiting drugs at the time of admission,
- active systemic disease (e.g., malignancy, thyroid disorders chronic inflammatory diseases, liver dysfunction),
- left ventricular systolic dysfunction (ejection fraction <50%),
- glomerular filtration rate <60 mL/min/1.73m2,
- allergy to ASA or clopidogrel, coagulopathy,
- platelet counts below 100,000/μl and hematocrit levels below 29%, or exceeding 52%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Intravenous Nitrate Treatment on Antiplatelet Effects of Clopidogrel in Acute Coronary Syndrome Patients: A Pilot Study
This study aims to investigate whether intravenous nitrate given during non-ST-elevation myocardial infarction (non-STEMI) affects the platelet inhibition of clopidogrel.
- Conditions
- Acute Coronary Syndromes
- Keywords
- Intravenous nitrate, clopidogrel, acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control | isotonic infusion | |
| nitrate | nitrate infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Reactivity Unit level
Platelet Reactivity Unit <208
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Feb 2023
- Primary completion1 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Postgraduate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ARI, Bursa Postgraduate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878638
- Sponsor's protocol ID
- Bursa Yüksek İhtisas
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melek M, Ari H, Karakus A, Ari S, Tutuncu A, Bozat T. Impact of Intravenous Nitrate Treatment on Antiplatelet Effects of Clopidogrel in Acute Coronary Syndrome Patients: A Pilot Study. J Cardiovasc Pharmacol Ther. 2025 Jan-Dec;30:10742484251357147. doi: 10.1177/10742484251357147. Epub 2025 Jul 2.
PubMed 40605381
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intravenous Nitrate Treatment on Antiplatelet Effects of Clopidogrel in Acute Coronary Syndrome Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT06878638
- Acronym / sponsor ID
- Bursa Yüksek İhtisas
- Conditions
- Acute Coronary Syndromes
- Keywords
- Intravenous nitrate, clopidogrel, acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 17 Mar 2025 (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.
This study aims to investigate whether intravenous nitrate given during non-ST-elevation myocardial infarction (non-STEMI) affects the platelet inhibition of clopidogrel.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –isotonic infusion |
| nitrate | – | –nitrate infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- acute coronary syndrome patients
Key inclusion criteria (4 listed)
- diagnosed with non-STEMI
- Patients aged 18 to 75 years
- positive troponin levels,
- blood pressure above 120/70 mmHg
Key exclusion criteria (13 listed)
- Hemodynamically unstable and requiring urgent intervention,
- ST elevation on electrocardiography, atrial fibrillation,
- recurrent angina,
- use of narcotic analgesics (e.g., morphine), nitrates and glycoprotein IIb/IIIa inhibitors during hospitalization,
- history of coronary artery bypass graft (CABG) surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet Reactivity Unit level
Time frame: 48 hours
Platelet Reactivity Unit <208
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 40605381Melek M, Ari H, Karakus A, Ari S, Tutuncu A, Bozat T. Impact of Intravenous Nitrate Treatment on Antiplatelet Effects of Clopidogrel in Acute Coronary Syndrome Patients: A Pilot Study. J Cardiovasc Pharmacol Ther. 2025 Jan-Dec;30:10742484251357147. doi: 10.1177/10742484251357147. Epub 2025 Jul 2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Coronary Syndromes, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 17 Mar 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Reactivity Unit level (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06878638, which also lists 1 linked publication.
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 17 Mar 2025.