Colchicine and Spironolactone in Patients With MI / SYNERGY Stent Registry (CLEAR SYNERGY)

  • STATUS
    Recruiting
  • End date
    Mar 30, 2025
  • participants needed
    7000
  • sponsor
    Population Health Research Institute
Updated on 1 March 2022
diabetes
stemi
troponin
colchicine

Summary

The CLEAR SYNERGY trial will study the long term effects of treatments following PCI to treat myocardial infarction. These treatments address both the culprit artery (PCI with SYNERGY stent) as well as the non-culprit arteries (randomization to routine colchicine and spironolactone).

Description

This is a multicenter, international SYNERGY stent registry that is embedded within a randomized, blinded, double-dummy, 2x2 factorial design trial of colchicine versus placebo and spironolactone versus placebo in patients with myocardial infarction who have undergone primary percutaneous coronary intervention (PCI).

Details
Condition ST Elevation Myocardial Infarction, Non ST Elevation Myocardial Infarction
Treatment colchicine, Spironolactone, SYNERGY Bioabsorbable Polymer Drug-Eluting Stent, Colchicine-Placebo, Spironolactone-Placebo
Clinical Study IdentifierNCT03048825
SponsorPopulation Health Research Institute
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

a) Patients with STEMI referred for PCI within 12 hours of symptom onset, have a culprit lesion amenable to stenting, and with planned SYNERGY stent implantation for SYNERGY registry
OR
b) Patients with STEMI referred for PCI within 48 hours of symptom onset, not
prospectively enrolled in SYNERGY stent registry
OR
c) Patients with diagnosis of Non STEMI with ischemic symptoms and either Hs
Troponin > or = 300x ULN or Troponin > or = 200x ULN who have undergone PCI
with one of the
following
i. LVEF< or =45% ii. Diabetes iii. Multivessel CAD defined as 50% stenosis in 2nd major epicardial vessel iv. Prior MI 2. Able to be enrolled/randomized within 72 hours of index PCI (however patients should be randomized as soon as possible after PCI) 3. Written informed consent

Exclusion Criteria

Age 18 years
Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
Any medical, geographic, or social factor making study participation impractical or precluding required follow-up
Systolic blood pressure <90 mm Hg
Active diarrhea
Known allergy or contraindication to everolimus, the SYNERGY stent or any of its components
Unable to receive dual antiplatelet therapy
Any contraindication or known intolerance to colchicine or spironolactone
Requirement for colchicine or mineralocorticoid antagonist for another indication
History of cirrhosis or current severe hepatic disease
Current or planned use of any of: cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics
Creatinine clearance <30 mL/min/1.73 m2
Serum Potassium >5.0 meq/L
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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