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CLEAR SYNERGY Neutrophil Substudy

Jun 11, 2019

Overview

 

CLEAR SYNERGY is an international, randomized placebo controlled trial of the poisonous alkaline colchicine and antagonist treatment of spironolactone in patients with a history of a heart attack(s). Blood is drawn from the participants initially and at a 3 months follow-up. They will have an also have an additional 2 tablespoons of blood drawn.

 

The sub study objectives are to:

 

  • Assess the effect of colchicine on neutrophil activation in response to heart attacks.
  • Examine clinical and genetic factors that determine heterogeneity of treatment response and distinguish colchicine responders from people who don’t respond.
  • Explore the derivation of a risk score that includes markers of neutrophil activity and is associated with adjudicated MACE, an endpoint or cardiovascular research, over 3 years after the heart attacks, and assess the impact of colchicine on the relation between this risk score and MACE.

 

Study Information

 

This is an observational study that began on March 4, 2019 and is estimated to be completed by February 1, 2021. This is an estimated 670 participants.

 

Inclusion Criteria

 

  • All sexes, ages 19 to 110 years old
  • Patients who are randomized to the drug RCT portion of the CLEAR SYNERGY (OASIS 9) trial will be eligible for participation in this Neutrophil biomarker substudy.

 

Exclusion Criteria

 

  • Use of anti-inflammatory agents (except aspirin)
  • Active infection

 

Location

 

You may participate in this study at NYU School of Medicine in New York, New York, United States, 10016. If you have any questions please contact Fatmira Curovic at 646-501-9648 or at fatmira.curovic@nyumc.org. You may also contact Binita Shah, MD.

 

Sponsors/Collaborators

 

This study is sponsored by NYU Langone Health, the Population Health Research Institute, the National Heart, Lung, and Blood Institute (NHLBI). Binita Shah, MD, from NYU School of Medicine will serve as the Principal Investigator.

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