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Treatment of Reperfusion Event by Vitamin C Infusion (TREVI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01090895
First received: March 18, 2010
Last updated: March 8, 2016
Last verified: March 2016

March 18, 2010
March 8, 2016
March 2010
October 2017   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
  • Specific key observations used to measure the effect of experimental treatment in this study are the incidence of Major Adverse Cardiovascular Events. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
  • Size of the infarct, assessed by measurements of cardiac biomarkers. [ Time Frame: 3-5 days ] [ Designated as safety issue: Yes ]
    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.
Complete list of historical versions of study NCT01090895 on ClinicalTrials.gov Archive Site
  • Myocardial damage and microcoronary disfunction by cardiac magnetic resonance imaging [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
  • Late incidence of Major Adverse Cardiovascular Events. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Cardiovascular Death, Myocardial Infarction, Stent Thrombosis, Repeat Revascularization, Stroke, Transient Ischemic Attack
Size of the infarct assed by cardiac magnetic resonance imaging [ Time Frame: 5 days ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Treatment of Reperfusion Event by Vitamin C Infusion
Effect of Vitamin C Infusion on Coronary Reperfusion Indexes

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Angina Pectoris
  • Drug: Vitamin C
    Intravenous infusion of vitamin C (1 g) 10 minutes before percutaneous coronary intervention.
    Other Name: Ascorbic Acid
  • Drug: Placebo
    Intravenous infusion of placebo(saline solution) 10 minutes before percutaneous coronary intervention.
    Other Name: Saline solution
  • Active Comparator: Vitamin C
    Vitamin C infusion
    Intervention: Drug: Vitamin C
  • Placebo Comparator: Placebo
    Saline solution
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2018
October 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years   (Adult, Senior)
No
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
 
NCT01090895
Violi012009
Yes
No
Not Provided
Francesco Violi, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Study Chair: Francesco Violi, Full Prof Divisione di Prima Clinica Medica - Sapienza University of Rome
University of Roma La Sapienza
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP