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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02044146
Other study ID # 20130601
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date September 2014
Est. completion date June 2017

Study information

Verified date October 2018
Source Ottawa Heart Institute Research Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 2017
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients: age >18 yrs, < 75yrs

-> 60 kg ( since March 2015 age >75 and < 60 kg eligible - but prasugrel reduced to 5mg daily if randomized to personalized therapy arm)

- NSTEMI undergoing PCI will be eligible

Exclusion Criteria:

- Patients will be excluded if they have: i) a contra-indication for clopidogrel or prasugrel or ticagrelor (as per monograph), ii) have an intolerance to aspirin, iii) have absolute requirement for ticagrelor or prasugrel (e.g. stent thrombosis, allergic reaction to clopidogrel), iv) requirement for anti-coagulation treatment, v) a history of stroke, TIA or intracranial hemorrhage , vi) a platelet count < 100,000/µl, vii) a known bleeding diathesis, viii) hematocrit <30% or >52%, ix) severe liver dysfunction, x) renal insufficiency (creatinine clearance < 30ml/min), xi) adjuvant therapy with a glycoprotein IIbIIIa inhibitor.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ticagrelor, Prasugrel, Clopidogrel


Locations

Country Name City State
Canada Montreal Heart Institute Montreal Quebec
Canada University of Ottawa Heart Institute Ottawa Ontario

Sponsors (2)

Lead Sponsor Collaborator
Ottawa Heart Institute Research Corporation Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Cost Evaluate cost involved in each strategy 1 month, 6 months
Other Genetic factors associated to outcomes Exploratory analysis of other potential genetic variants to outcomes 1 month, 6 months
Primary Proportion of Patients in Therapeutic Window The primary endpoint is the proportion of patients outside of the "therapeutic window" in the personalized therapy (PN) arm compared to the ticagrelor (TG) arm at 1 month. The "therapeutic window" will be defined by platelet function values (VerifyNow P2Y12 assay - P2Y12 reaction unit (PRU) = 208 (correlated with decreased ischemic outcomes) AND PRU >= 85 (correlated with decrease bleeding). This is a surrogate of NACE (net adverse clinical events) 1 month
Secondary P2Y12 Reaction Unit (PRU) change in PRU from baseline, day 1 to 1 month in each of the groups Baseline, Day 1, 1 month
Secondary Bleeding the incidence of bleeding (defined by TIMI minor and major bleeds) among groups 1 month, 6 months
Secondary MACE combined clinical endpoint (MACE) including death, myocardial infarction(MI) or urgent target vessel revascularization (TVR) 1 month, 6 months
Secondary Stent thrombosis stent thrombosis (ARC definite/probable) 1 month, 6 month
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