Acute Coronary Syndrome Clinical Trial
Official title:
Reassessment of Anti-Platelet Therapy Using InDividualized Strategies - Modifying Acute CoroNary Syndrome Algorithms Based on Genetic and Demographic Evaluation: The RAPID-MANAGE Study
In patients with heart attacks, the treatment of choice is to restore blood flow with
percutaneous coronary intervention (PCI) (use of stents (metal meshes) to open blockages).
After PCI, the standard drug treatment includes aspirin and clopidogrel. These medications
block full function of the platelet cells, which are responsible for clotting. Despite their
use, patients after PCI are at risk for heart attacks, sudden clotting of stents or death. A
major contributor may be resistance to clopidogrel. New more potent drugs, which can overcome
the resistance, are now available; however, they come with an increase chance of severe
bleeding and costs. An ideal solution would be to identify at-risk patients and selectively
treat them with more potent drugs, while lower-risk patients continue with clopidogrel. This
type of strategy (personalized strategy) would decrease heart attacks and death (compared to
clopidogrel), while also preventing bleeding complications (compared to treating all patients
with the new drugs).
Of resistant patients, many carry genes (inherited units) that prevent proper absorption of
clopidogrel. Our group has developed and tested a new bedside genetic test, which identifies
carriers of at-risk genes. However, this technique alone does not identify all at-risk
patients. Consequently, we have now devised a novel tool, which combines genetics with
patient characteristics to identify high-risk patients.
The present study combines this new tool into a strategy for personalized treatment. Patients
with heart attacks who undergo PCI will be randomly assigned to 1 of 3 strategies: a) new
personalized strategy, b) clopidogrel strategy (previous standard drug) or c) ticagrelor
strategy (stronger approved drug). The function of the platelet cells will be measured at 1
month to determine potential benefits. Evaluation of this new personalized strategy is
important for improving patient outcomes after PCI. The hypothesis is that patients receiving
a personalized strategy will have decrease risk for future heart attacks and bleeding.
n/a
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