Treatment of Reperfusion Event by Vitamin C Infusion

NCT01090895 | Unknown Phase 4 DMC

• 1 other identifier: Violi012009
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Angina Pectoris

Keywords

Percutaneous Coronary Intervention; Vitamin C; Biomarkers; Magnetic Risonance

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (4)

• Myocardial damage and microcoronary disfunction by cardiac magnetic resonance imaging

  7 days

• Improvement of reperfusion indexes (corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade)

  post PCI

• Early incidence of Major Adverse Cardiovascular Events.

  1 month

• Late incidence of Major Adverse Cardiovascular Events.

  3 months

Study Arms (2)

Vitamin C

ACTIVE COMPARATOR

Vitamin C infusion

Drug: Vitamin C

Placebo

PLACEBO COMPARATOR

Saline solution

Drug: Placebo

Interventions

Vitamin C DRUG

Intravenous infusion of vitamin C (1 g) 10 minutes before percutaneous coronary intervention.

Also known as: Ascorbic Acid

Vitamin C

Placebo DRUG

Intravenous infusion of placebo(saline solution) 10 minutes before percutaneous coronary intervention.

Also known as: Saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza Università di Roma

Rome, Italy, 00161, Italy

RECRUITING

Related Publications (8)

• 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.

  PMID: 15917194 BACKGROUND

• 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.

  PMID: 7073791 BACKGROUND

• 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.

  PMID: 20170881 BACKGROUND

• 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.

  PMID: 19336704 BACKGROUND

• 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.

  PMID: 17664149 BACKGROUND

• 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.

  PMID: 21636808 BACKGROUND

• 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.

  PMID: 25074252 BACKGROUND

• 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.

  PMID: 20629665 RESULT

MeSH Terms

Conditions

Angina Pectoris

Interventions

Ascorbic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Francesco Violi, Full Prof

  Divisione di Prima Clinica Medica - Sapienza University of Rome

  STUDY CHAIR

Central Study Contacts

Francesco Violi, Full Prof

CONTACT

+39-06-4461933; francesco.violi@uniroma1.it

Stefania Basili, Ass Prof

CONTACT

+39-06-49974678; stefania.basili@uniroma1.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor of internal medicine

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 23, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 9, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)