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Treatment of Reperfusion Event by Vitamin C Infusion (TREVI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by University of Roma La Sapienza.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01090895
First received: March 18, 2010
Last updated: November 27, 2012
Last verified: November 2012

March 18, 2010
November 27, 2012
March 2010
January 2013   (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: 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.
Same as current
Complete list of historical versions of study NCT01090895 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Treatment of Reperfusion Event by Vitamin C Infusion
Effect of Vitamin C Infusion on Reperfusion Injury in Acute Myocardial Infarction.

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
Myocardial Infarction
  • Drug: Vitamin C
    After baseline collection of blood samples, computer-generated random sequence were used for randomization to an intravenous infusion of vitamin C (1 g/L of saline solution at 24 mg/min) or placebo(saline solution) during intervention. Less than 10 minutes before direct stenting, the patients received the intravenous infusion.
  • Drug: Placebo
    After baseline collection of blood samples, computer-generated random sequence were used for randomization to an intravenous infusion of vitamin C (1 g/L of saline solution at 24 mg/min) or placebo(saline solution) during intervention. Less than 10 minutes before direct stenting, the patients received the intravenous infusion.
  • Active Comparator: Vitamin C
    Intervention: Drug: Vitamin C
  • Placebo Comparator: Placebo
    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 2013
January 2013   (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
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
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
November 2012

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