Back to resultsTreatment of Reperfusion Event by Vitamin C Infusion (TREVI)
Primary Purpose
Angina Pectoris
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Vitamin C
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Angina Pectoris focused on measuring Percutaneous Coronary Intervention, Vitamin C, Biomarkers, Magnetic Risonance
Eligibility Criteria
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
Sites / Locations
- Sapienza Università di RomaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin C
Placebo
Arm Description
Vitamin C infusion
Saline solution
Outcomes
Primary Outcome Measures
Specific key observations used to measure the effect of experimental treatment in this study are the incidence of Major Adverse Cardiovascular Events.
Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
Secondary Outcome Measures
Myocardial damage and microcoronary disfunction by cardiac magnetic resonance imaging
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)
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.
Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
Late incidence of Major Adverse Cardiovascular Events.
Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
Full Information
NCT ID
NCT01090895
First Posted
March 18, 2010
Last Updated
March 8, 2016
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01090895
Brief Title
Treatment of Reperfusion Event by Vitamin C Infusion
Acronym
TREVI
Official Title
Effect of Vitamin C Infusion on Coronary Reperfusion Indexes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris
Keywords
Percutaneous Coronary Intervention, Vitamin C, Biomarkers, Magnetic Risonance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C
Arm Type
Active Comparator
Arm Description
Vitamin C infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline solution
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
Ascorbic Acid
Intervention Description
Intravenous infusion of vitamin C (1 g) 10 minutes before percutaneous coronary intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline solution
Intervention Description
Intravenous infusion of placebo(saline solution) 10 minutes before percutaneous coronary intervention.
Primary Outcome Measure Information:
Title
Specific key observations used to measure the effect of experimental treatment in this study are the incidence of Major Adverse Cardiovascular Events.
Description
Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Myocardial damage and microcoronary disfunction by cardiac magnetic resonance imaging
Description
Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) would limit the size of damage within 7 days after PCI.
Time Frame
7 days
Title
Improvement of reperfusion indexes (corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade)
Description
Prophylactic Vitamin C Intravenous Infusion at the time of percutaneous coronary intervention (PCI) could improve the reperfusion indexes.
Time Frame
post PCI
Title
Early incidence of Major Adverse Cardiovascular Events.
Description
Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
Time Frame
1 month
Title
Late incidence of Major Adverse Cardiovascular Events.
Description
Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Violi, Full Prof
Phone
+39-06-4461933
Email
francesco.violi@uniroma1.it
First Name & Middle Initial & Last Name or Official Title & Degree
Stefania Basili, Ass Prof
Phone
+39-06-49974678
Email
stefania.basili@uniroma1.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Violi, Full Prof
Organizational Affiliation
Divisione di Prima Clinica Medica - Sapienza University of Rome
Official's Role
Study Chair
Facility Information:
Facility Name
Sapienza Università di Roma
City
Rome
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Violi, Full Prof
Phone
+39-06-4461933
Email
francesco.violi@uniroma1.it
First Name & Middle Initial & Last Name & Degree
Stefania Basili, Ass Prof
Phone
+39-06-49974678
Email
stefania.basili@uniroma1.it
First Name & Middle Initial & Last Name & Degree
Tanzilli Gaetano, Prof.
First Name & Middle Initial & Last Name & Degree
Mangieri Enrico, Prof.
First Name & Middle Initial & Last Name & Degree
Raparelli Valeria, Prof.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15917194
Citation
Pignatelli P, Sanguigni V, Paola SG, Lo Coco E, Lenti L, Violi F. Vitamin C inhibits platelet expression of CD40 ligand. Free Radic Biol Med. 2005 Jun 15;38(12):1662-6. doi: 10.1016/j.freeradbiomed.2005.02.032. Epub 2005 Mar 23.
Results Reference
background
PubMed Identifier
7073791
Citation
Cordova C, Musca A, Violi F, Perrone A, Alessandri C. Influence of ascorbic acid on platelet aggregation in vitro and in vivo. Atherosclerosis. 1982 Jan;41(1):15-9. doi: 10.1016/0021-9150(82)90064-8.
Results Reference
background
PubMed Identifier
20170881
Citation
Basili S, Tanzilli G, Mangieri E, Raparelli V, Di Santo S, Pignatelli P, Violi F. Intravenous ascorbic acid infusion improves myocardial perfusion grade during elective percutaneous coronary intervention: relationship with oxidative stress markers. JACC Cardiovasc Interv. 2010 Feb;3(2):221-9. doi: 10.1016/j.jcin.2009.10.025.
Results Reference
background
PubMed Identifier
19336704
Citation
Violi F, Cangemi R. Antioxidant supplements and cardiovascular disease in men. JAMA. 2009 Apr 1;301(13):1335; author reply 1336-7. doi: 10.1001/jama.2009.314. No abstract available.
Results Reference
background
PubMed Identifier
17664149
Citation
Cangemi R, Angelico F, Loffredo L, Del Ben M, Pignatelli P, Martini A, Violi F. Oxidative stress-mediated arterial dysfunction in patients with metabolic syndrome: Effect of ascorbic acid. Free Radic Biol Med. 2007 Sep 1;43(5):853-9. doi: 10.1016/j.freeradbiomed.2007.06.002. Epub 2007 Jun 13.
Results Reference
background
PubMed Identifier
21636808
Citation
Basili S, Pignatelli P, Tanzilli G, Mangieri E, Carnevale R, Nocella C, Di Santo S, Pastori D, Ferroni P, Violi F. Anoxia-reoxygenation enhances platelet thromboxane A2 production via reactive oxygen species-generated NOX2: effect in patients undergoing elective percutaneous coronary intervention. Arterioscler Thromb Vasc Biol. 2011 Aug;31(8):1766-71. doi: 10.1161/ATVBAHA.111.227959. Epub 2011 Jun 2.
Results Reference
background
PubMed Identifier
25074252
Citation
Basili S, Tanzilli G, Raparelli V, Calvieri C, Pignatelli P, Carnevale R, Dominici M, Placanica A, Arrivi A, Farcomeni A, Barilla F, Mangieri E, Violi F. Aspirin reload before elective percutaneous coronary intervention: impact on serum thromboxane b2 and myocardial reperfusion indexes. Circ Cardiovasc Interv. 2014 Aug;7(4):577-84. doi: 10.1161/CIRCINTERVENTIONS.113.001197. Epub 2014 Jul 29.
Results Reference
background
PubMed Identifier
20629665
Citation
Pignatelli P, Tanzilli G, Carnevale R, Di Santo S, Loffredo L, Celestini A, Proietti M, Tovaglia P, Mangieri E, Basili S, Violi F. Ascorbic acid infusion blunts CD40L upregulation in patients undergoing coronary stent. Cardiovasc Ther. 2011 Dec;29(6):385-94. doi: 10.1111/j.1755-5922.2010.00168.x. Epub 2010 Jul 12.
Results Reference
result
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Treatment of Reperfusion Event by Vitamin C Infusion
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