Treatment of Reperfusion Event by Vitamin C Infusion (TREVI)
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ClinicalTrials.gov Identifier: NCT01090895 |
Recruitment Status
:
Recruiting
First Posted
: March 23, 2010
Last Update Posted
: March 9, 2016
|
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Primary Hypothesis: Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) would limit the size of the infarct, assessed by measurements of cardiac biomarkers, during acute myocardial infarction.
Secondary Hypotheses: Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) would limit the size of the infarct, as measured by the area of delayed hyperenhancement that was seen on cardiac magnetic resonance imaging (MRI), assessed on day 5 after infarction, during acute myocardial infarction.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Angina Pectoris | Drug: Vitamin C Drug: Placebo | Phase 4 |
This is a multicenter, prospective, controlled, randomized study that will be conducted at up to 5 centers in Italy. All patients who meet the eligibility criteria will be randomized to receive during surgical procedure an intravenous infusion of Vitamin C or Placebo.
Patients will have repeat clinical follow-up to 5 days, 3 and 6 months and 1 year.
The new angiography evaluation will be done if necessary. The study population will consist of at least 100 patients who presented within 12 hours after the onset of chest pain, who had ST-segment elevation of more than 0.1 mV in two contiguous leads, and for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI). Following confirmation of eligibility criteria, patients will be randomized in a 1:1 ratio to receive prophylactic infusion of Vitamin C or Placebo. The coronary angiograms will be assessed at a core laboratory with Quantitative Coronary Angiography.
The incidence of clinical events, including death, myocardial infarction, target vessel revascularization, stent thrombosis, will be evaluated at 1, 3, 6 and, 12 months.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Vitamin C Infusion on Coronary Reperfusion Indexes |
Study Start Date : | March 2010 |
Estimated Primary Completion Date : | October 2017 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Vitamin C
Vitamin C infusion
|
Drug: Vitamin C
Intravenous infusion of vitamin C (1 g) 10 minutes before percutaneous coronary intervention.
Other Name: Ascorbic Acid
|
Placebo Comparator: Placebo
Saline solution
|
Drug: Placebo
Intravenous infusion of placebo(saline solution) 10 minutes before percutaneous coronary intervention.
Other Name: Saline solution
|
- Specific key observations used to measure the effect of experimental treatment in this study are the incidence of Major Adverse Cardiovascular Events. [ Time Frame: 12 months ]Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
- Myocardial damage and microcoronary disfunction by cardiac magnetic resonance imaging [ Time Frame: 7 days ]Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) would limit the size of damage within 7 days after PCI.
- Improvement of reperfusion indexes (corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade) [ Time Frame: post PCI ]Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) could improve the reperfusion indexes.
- Early incidence of Major Adverse Cardiovascular Events. [ Time Frame: 1 month ]Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
- Late incidence of Major Adverse Cardiovascular Events. [ Time Frame: 3 months ]Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects who presented within 12 hours after the onset of chest pain, who had ST-segment elevation of more than 0.1 mV in two contiguous leads, and for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI)
- Patients will be eligible for the study whether they were undergoing primary PCI.
- Signed written informed consent
Exclusion Criteria:
- Patients with cardiac arrest, ventricular fibrillation, cardiogenic shock, stent thrombosis, previous acute myocardial infarction, or angina within 48 hours before infarction were not included in the study
- Patients with evidence of coronary collaterals (2-3 Rentrop) to the region at risk on initial coronary angiography (at the time of admission) will be excluded
- The patient has impaired renal function (creatinine > 3.0 mg/dl)
- The patient has known allergies to aspirin, clopidogrel bisulfate and ticlopidine, heparin, contrast media or stainless steel that cannot be managed medically
- The patient needs therapy with warfarin
- The patient has a life expectancy less than 12 months
- Recipient of heart transplant
- The patient is currently participating in an investigational drug or another device study

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): NCT01090895
Contact: Francesco Violi, Full Prof | +39-06-4461933 | francesco.violi@uniroma1.it | |
Contact: Stefania Basili, Ass Prof | +39-06-49974678 | stefania.basili@uniroma1.it |
Italy | |
Sapienza Università di Roma | Recruiting |
Rome, Italy, 00161 | |
Contact: Francesco Violi, Full Prof +39-06-4461933 francesco.violi@uniroma1.it | |
Contact: Stefania Basili, Ass Prof +39-06-49974678 stefania.basili@uniroma1.it | |
Sub-Investigator: Tanzilli Gaetano, Prof. | |
Sub-Investigator: Mangieri Enrico, Prof. | |
Principal Investigator: Raparelli Valeria, Prof. |
Study Chair: | Francesco Violi, Full Prof | Divisione di Prima Clinica Medica - Sapienza University of Rome |
Publications of Results:
Other Publications:
Responsible Party: | Francesco Violi, Full professor of internal medicine, University of Roma La Sapienza |
ClinicalTrials.gov Identifier: | NCT01090895 History of Changes |
Other Study ID Numbers: |
Violi012009 |
First Posted: | March 23, 2010 Key Record Dates |
Last Update Posted: | March 9, 2016 |
Last Verified: | March 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Francesco Violi, University of Roma La Sapienza:
Percutaneous Coronary Intervention Vitamin C Biomarkers Magnetic Risonance |
Additional relevant MeSH terms:
Angina Pectoris Chest Pain Pain Neurologic Manifestations Nervous System Diseases Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Signs and Symptoms Vitamins Ascorbic Acid Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |