Nitrate - Clopidogrel - Acute Coronary Syndrome
Impact of Intravenous Nitrate Treatment on Antiplatelet Effects of Clopidogrel in Acute Coronary Syndrome Patients: A Pilot Study
1 other identifier
observational
20
1 country
1
Brief Summary
This study aims to investigate whether intravenous nitrate given during non-ST-elevation myocardial infarction (non-STEMI) affects the platelet inhibition of clopidogrel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
March 5, 2025
CompletedFirst Posted
Study publicly available on registry
March 17, 2025
CompletedMarch 17, 2025
March 1, 2025
11 months
March 5, 2025
March 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Platelet Reactivity Unit level
Platelet Reactivity Unit \<208
48 hours
Study Arms (2)
control
isotonic infusion
nitrate
nitrate infusion
Eligibility Criteria
acute coronary syndrome patients
You may qualify if:
- diagnosed with non-STEMI
- Patients aged 18 to 75 years
- positive troponin levels,
- blood pressure above 120/70 mmHg
You may not qualify if:
- 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,
- 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%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa Yüksek İhtisas Hastanesi
Bursa, 16340, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 40605381DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Doctor
Study Record Dates
First Submitted
March 5, 2025
First Posted
March 17, 2025
Study Start
February 1, 2023
Primary Completion
January 1, 2024
Study Completion
April 1, 2024
Last Updated
March 17, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share