Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05831462 |
| Other study ID # |
Ticagrelor in post PPCI |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
April 2023 |
| Source |
Assiut University |
| Contact |
Mohamed Taha Galal, MSc cardiology |
| Phone |
+10269050 |
| Email |
mohamedtahagalal90[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Primary objective: to evaluate the efficacy and safety of De-escalation to lower dose
Ticagrelor (60 mg BID) plus Aspirin (75 mg OD) versus continuation of standard dose
Ticagrelor (90 mg BID) plus Aspirin (75 mg OD), 1 month after primary PCI for STEMI, in
diabetic patients.
Secondary objectives:
To compare tolerability and discontinuation of Ticagrelor in both doses. To compare the 1ry
safety & efficacy endpoints in subgroups with different thrombotic/ischemic risk
Description:
[15:42, 18/02/2023] M Taha: Ticagrelor at a maintenance dose of 90 mg twice a day (bid) was
shown to provide greater and more consistent platelet P2Y12 inhibition than clopidogrel in
patients with stable coronary artery disease (PA Gurbal, KP Bliden et al 2009) and acute
coronary syndromes (ACS) (RF Storey, S Husted et al 2007).
The PLATO (Platelet Inhibition and Patient Outcomes) trial demonstrated the superior efficacy
of ticagrelor, given at a maintenance dose of 90 mg bid, compared with clopidogrel for up to
1 year in patients with ACS (L Wallentin, RC Becker et al 2009) [15:42, 18/02/2023] M Taha:
Consequently, this regimen of ticagrelor is recommended in international guidelines as
first-line therapy for up to 1 year following either non-ST-segment elevation ACS (P Damman,
AW van't Hof et al 2017) or ST-segment elevation myocardial infarction managed with primary
percutaneous coronary intervention (PT O'gara, FG Kushner et al 2013).
In the PEGASUS-TIMI 54 trial, ticagrelor maintenance doses of 60 mg b.i.d and 90 mg b.i.d
were clinically equally effective in stable patients more than 1 year after acute myocardial
infarction (AMI), with a better tolerability of treatment observed with the lower dose
(Bonaca MP, Bhatt DL et al 2016).
[15:42, 18/02/2023] M Taha: n a pharmacokinetic & pharmacodynamic substudy of the
PEGASUS-TIMI 54 trial, ticagrelor 60 mg bid achieved high levels of peak and trough platelet
inhibition in nearly all patients, similar to that with 90 mg bid, helping to explain the
efficacy of the lower ticagrelor dose in the trial.1 Most recently, in a pharmacodynamic
randomized controlled study (ELECTRA), lowering ticagrelor maintenance dose to 60 mg b.i.d,
on day 30 following acute MI, was shown to confer an adequate antiplatelet effect that is
comparable to the standard maintenance dose of 90 mg b.i.d.2
