Acute ST Segment Elevation Myocardial InfarctionPhase 3EASE-PRM-PCINCT01878344
Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention
A Phase 3 study testing NAC and Saline in people with Acute ST Segment Elevation Myocardial Infarction, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of N-acetyl cysteine on major cardiac and cerebral events in patients undergoing primary percutaneous coronary intervention who have moderate to high risk for contrast induced nephropathy. In a sub-group of patients coronary flow reserve will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute ST Segment Elevation Myocardial Infarction
- What is being tested?
- NAC and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Acute ST Elevation Myocardial Infarction undergoing Primary Percutaneous Coronary intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy (Mehran Score ≥5)
Who cannot join
- Patients >18 years old with moderate to high risk for contrast induced nephropathy undergoing percutaneous coronary intervention
- Low risk for contrast induced nephropathy (Mehran Score <5)
- Use of nephrotoxic agents (NSAIDs, aminoglycosides,recent contrast injection...)
- Infection
- Pregnancy, Lactation
- Renal failure requiring dialysis
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- Hepatic failure
- Allergy to NAC
- History of Asthma
- Chronic nitrate usage
- Malignancy
- Use of corticosteroids
- Leucocytosis,Thrombocytosis,Anemia
- Blood pressure of >180/100mmHg despite anti-hypertensive therapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University
Isparta, Mediterranean Region, 32260
About this study
Official title: Effects of N-acetyl Cysteine on Major Cardiac and Cerebral Events in Patients Undergoing Primary Percutaneous Coronary Intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy
The aim of this study is to evaluate the effects of N-acetyl cysteine on major cardiac and cerebral events in patients undergoing primary percutaneous coronary intervention who have moderate to high risk for contrast induced nephropathy.
In a sub-group of patients coronary flow reserve will be evaluated.
- Being tested
- NAC, Saline
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NACDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| n-acetyl cysteine | Experimental | 30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure Receives: Drug: NAC |
| Saline | Placebo comparator | 30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiac and cerebral events
Measured: 1 year
Secondary outcomes (1)
NAC side effects (Asthma exacerbation, Pruritus, Dyspnea)
Measured: during hospitalization at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2018
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ST Segment Elevation Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ozaydin, MD, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878344
- Sponsor's protocol ID
- ozaydin290
- Acronym
- EASE-PRM-PCI
- Status last verified
- May 2025
- First submitted
- 12 Jun 2013
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of N-acetyl Cysteine on Major Cardiac and Cerebral Events in Patients Undergoing Primary Percutaneous Coronary Intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy
- ClinicalTrials.gov ID
- NCT01878344
- Acronym / sponsor ID
- EASE-PRM-PCI / ozaydin290
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jun 2013 (estimated)
- 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.
The aim of this study is to evaluate the effects of N-acetyl cysteine on major cardiac and cerebral events in patients undergoing primary percutaneous coronary intervention who have moderate to high risk for contrast induced nephropathy.
In a sub-group of patients coronary flow reserve will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n-acetyl cysteine | Experimental | Drug: NAC30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure |
| Saline | Placebo comparator | Drug: Saline30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Acute ST Elevation Myocardial Infarction undergoing Primary Percutaneous Coronary intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy (Mehran Score ≥5)
Key exclusion criteria (14 listed)
- Patients >18 years old with moderate to high risk for contrast induced nephropathy undergoing percutaneous coronary intervention
- Low risk for contrast induced nephropathy (Mehran Score <5)
- Use of nephrotoxic agents (NSAIDs, aminoglycosides,recent contrast injection...)
- Infection
- Pregnancy, Lactation
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 |
|---|---|---|
| NAC | Drug | n-acetyl cysteine |
| Saline | Drug | Saline |
Primary outcome
Major cardiac and cerebral events
Time frame: 1 year
1 secondary outcome
NAC side effects (Asthma exacerbation, Pruritus, Dyspnea)
Time frame: during hospitalization at 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
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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?
A Phase 3 study testing NAC and Saline in people with Acute ST Segment Elevation Myocardial Infarction, run by Suleyman Demirel University 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 1 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 20 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Major cardiac and cerebral events (time frame: 1 year). 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 20 May 2025.