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CYP2C19 Genotyping for Heart Conditions
Study Summary
This trial will test if adding genetic and chemical tests to the standard care for heart attack patients could improve outcomes.
- Acute Coronary Syndrome
- Heart Attack
- Angina
- Myocardial Infarction
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have a serious mental health condition, according to the doctor.You have a positive troponin test result for acute coronary syndrome.You are between 18 and 80 years old when you join the study.You cannot take clopidogrel if you are allergic to it or have active bleeding like a stomach ulcer or bleeding in the brain.You cannot participate if you are allergic to prasugrel, have active bleeding issues like ulcers or bleeding in the brain, or have had a previous stroke or transient ischemic attack (TIA).You had a severe heart condition that needed a ventilator or special medication for more than a week in the last two weeks.You need to take blood-thinning medication like warfarin, rivaroxaban, dabigatran, or apixaban at the same time as the study drug.You have had a liver transplant or plan to have one within the next year.You are planning to have a procedure called left heart catheterization and PCI.You are currently taking or are expected to take dual antiplatelet therapy with a P2Y12 inhibitor.
- Group 1: Precision medicine implementation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this trial include participants below the age of sixty?
"As per the predetermined parameters, any individual between 18 and 80 years of age is eligible to take part in this research."
Are recruitment efforts currently underway for this experiment?
"According to the details posted on clinicaltrials.gov, no participants are being sought for this trial at present; it was initially listed in March 2020 and last updated almost a year ago. However, there are 486 other studies that require volunteers right now."
Who meets the qualifications to partake in this medical trial?
"To be considered for this study, individuals must present with unstable angina pectoris and have attained the age of majority but not surpassed 80 years. A total of 200 participants are needed for the trial to move forward."
Does this therapy have the endorsement of government health regulators?
"There is ample evidence to suggest this treatment's safety, thus earning it a score of 3 on our scale. The Phase 4 trial status confirms the FDA’s approval for this medication."
What aims are researchers hoping to achieve through this experiment?
"This 12-month study intends to assess the viability of pharmacogenetics to guide antiplatelet therapy. Secondary objectives include evaluating patient reported outcomes via PROMIS subscales for anxiety, depression, and social ability; where higher scores indicate a more severe outcome."
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