NCT00855257: EVANACS

Assessment of Endothelial Vasomotricity After Treatment by Nicotinic Acid in Patients Presenting a Recent Acute Coronary Syndrome.

Completed Phase 3 Last updated 8 July 2009

What this trial tests

Phase 3 trial testing Acid Nicotinique in Acute Coronary Syndrome (ACS) in 93 participants. Completed in 1 May 2009.

Timeline

1 June 2007

Primary endpoint
1 May 2009

1 May 2009

Quick facts

Lead sponsor	French Cardiology Society
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	93
Start date	1 June 2007
Primary completion	1 May 2009
Estimated completion	1 May 2009
Sites	1 location across France

Drugs / interventions tested

• Acid Nicotinique — full drug profile →
• Placebo

Conditions studied

• Acute Coronary Syndrome (ACS) — all drugs for Acute Coronary Syndrome (ACS) →

Sponsor

French Cardiology Society

Who can join

Adults 18 to 75, any sex, with Acute Coronary Syndrome (ACS). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Measure of endothelial function by high resolution echography in response to nitric agent
  Time frame: Within the first 7 days of ACS and 3 months by treatment with nicotinic acid

Sponsor's own description

The investigators' work proposes to evaluate the effectiveness of the Acid Nicotinique (Niaspan®), only molecule currently marketed, ready to raise the plasmatic levels of HDL-c. This effectiveness will be tested among patients having presented recently an acute coronary syndrome. The effectiveness of the molecule will be appreciated versus placebo after randomization.

The technique of evaluation of this effectiveness will be the analysis of the vasodilatation endothelial-dependent measured on the level huméral (by echography high resolution).

The awaited result is an improvement of 2% in value absolute of this vasodilatation between the initial test and the end of study for the patients receiving the acid nicotinic versus those receiving the placebo (3 months of treatment after inclusion). The calculation of the sample necessary to achieve this goal envisages 70 patients led at the end of the study, divided into two groups of treatment (acid nicotinic or Placebo).

Such a result if it were obtained would be higher than that found in studies evaluating the effect on the vasomotricity endothelial statins or inhibitors of the enzyme of conversion.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. NAD⁺ metabolism: pathophysiologic mechanisms and therapeutic potential.
   Xie N, Zhang L, Gao W, Huang C, et al · · 2020 · cited 744× · PMID 33028824 · DOI 10.1038/s41392-020-00311-7
2. Therapeutic Potential of Emerging NAD+-Increasing Strategies for Cardiovascular Diseases.
   Rotllan N, Camacho M, Tondo M, Diarte-Añazco EMG, et al · · 2021 · cited 25× · PMID 34943043 · DOI 10.3390/antiox10121939