CLEAR SYNERGY Neutrophil Substudy
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 19 - 110 |
| Updated: | 3/21/2019 |
| Start Date: | March 4, 2019 |
| End Date: | February 1, 2022 |
| Contact: | Fatmira Curovic |
| Email: | fatmira.curovic@nyumc.org |
| Phone: | 646-501-9648 |
Studies on the Effects of Colchicine on Neutrophil Biology in Acute Myocardial Infarction: A Substudy of the CLEAR SYNERGY (OASIS 9) Trial
CLEAR SYNERGY is an international multi center 2x2 randomized placebo controlled trial of
colchicine and spironolactone in patients with STEMI. Subjects enrolled in the main CLEAR
SYNERGY trial will be asked to participate in this sub study (n=670) to undergo:
1. Evaluation of markers of neutrophil activity at randomization (baseline) and 3 months
follow-up in the colchicine versus placebo groups, and;
2. Examination of clinical and genetic factors that determine heterogeneity of treatment
response and distinguish colchicine responders from non- responders.
Participants undergo a blood draw at baseline and 3 months follow-up as part of the main
trial, and participants who also participate in this sub study will have an additional 2
tablespoons of blood drawn.
The sub study objectives are to:
1. Assess the effect of colchicine on neutrophil activation in response to STEMI.
2. Examine clinical and genetic factors that determine heterogeneity of treatment response
anddistinguish colchicine responders from non- responders.
3. Explore the derivation of a risk score that includes markers of neutrophil activity and
is associated with adjudicated MACE over 3 years after STEMI, and assess the impact of
colchicine on the relation between this risk score and MACE.
colchicine and spironolactone in patients with STEMI. Subjects enrolled in the main CLEAR
SYNERGY trial will be asked to participate in this sub study (n=670) to undergo:
1. Evaluation of markers of neutrophil activity at randomization (baseline) and 3 months
follow-up in the colchicine versus placebo groups, and;
2. Examination of clinical and genetic factors that determine heterogeneity of treatment
response and distinguish colchicine responders from non- responders.
Participants undergo a blood draw at baseline and 3 months follow-up as part of the main
trial, and participants who also participate in this sub study will have an additional 2
tablespoons of blood drawn.
The sub study objectives are to:
1. Assess the effect of colchicine on neutrophil activation in response to STEMI.
2. Examine clinical and genetic factors that determine heterogeneity of treatment response
anddistinguish colchicine responders from non- responders.
3. Explore the derivation of a risk score that includes markers of neutrophil activity and
is associated with adjudicated MACE over 3 years after STEMI, and assess the impact of
colchicine on the relation between this risk score and MACE.
Inclusion Criteria:
- 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
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