Acute Coronary Syndrome, Cardiovascular Diseases
Conditions
Brief summary
This is a pilot study that was conducted to prove the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. we advocate comparing the clinical efficacy rather than simple bioequivalence comparison.
Detailed description
Cardiovascular diseases are the leading cause of death worldwide. Ticagrelor, is an oral antiplatelet drug used in acute coronary syndrome. Although generic drugs are approved for their bioequivalence to the original product, they are not necessarily to be therapeutically equivalent. This study was conducted to prove the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. A loading dose of 180 mg ticagrelor named Brilique® or Ticaloguard® followed by a 90 mg twice daily regimen as maintenance dose was given to 14 and 15 volunteers in Ticaloguard and Brilique groups, respectively. The platelet aggregation on adenosine diphosphate (ADP) agonist was assessed at different time intervals .
Interventions
DRUGTicagrelor 90mg (Brilique)
compare the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers
DRUGTicagrelor 90mg (Ticaloguard)
compare the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The volunteers were randomly allocated to 2 groups, one receiving the brand drug and the other receiving the generic, each receiving a code indicating his/her group and the key of the codes could only be revealed by the principal investigator.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
volunteers of both sexes, aged between 18-64 years old
Exclusion criteria
* volunteers with any abnormalities in the complete blood count (CBC) at entry time * those with any medical conditions contraindicated with antiplatelet therapy * those taking aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or any over the counter medications (OTC) that contain medication such as, antihistamines, antibiotics in the previous month * volunteers with history of blood disorders or bleeding diathesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| testing degree of platelet inhibition of Ticalouguard versus the brand Brilique | 1 month | Testing the degree of platelet inhibition in both groups through performing platelet aggregation testing using Adenosine diphosphate as agonist |
Countries
Egypt
Outcome results
None listed