A Phase 3 interventional study of Ticagrelor 90mg and Ticagrelor 60mg in STEMI, NSTEMI and Unstable Angina, sponsored by Collegium Medicum w Bydgoszczy. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by Collegium Medicum w Bydgoszczy · Phase 3, Interventional, and Treatment
Among 24 studies testing ticagrelor in ST Elevation Myocardial Infarction — none open to participants now, 1 under way, none of them phase 3. Ticagrelor · ST Elevation Myocardial Infarction.
Among the 24 studies testing ticagrelor in ST Elevation Myocardial Infarction, this one has the largest planned enrollment, is the only one that started in 2022, is one of 6 in phase 3, and was the 22nd registered.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 4,500 is above the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →None of the 24 studies testing ticagrelor in ST Elevation Myocardial Infarction is open now.
Ticagrelor: first FDA approval 2011 (BRILINTA), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →24 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2022.
Median enrollment 94 across the 24 interventional studies. Of the 16 that completed or were terminated, 4 (25%) have results posted.
None of the 24 has an industry lead sponsor. The 10 most frequent:
Collegium Medicum w Bydgoszczy is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
Collegium Medicum w Bydgoszczy has 5 studies filed under ST Elevation Myocardial Infarction — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 24 studies testing ticagrelor in ST Elevation Myocardial Infarction, from their registry updates:
Nothing recorded among them since 2026-09-25.
The ELECTRA-SIRIO 2 study is a randomized, multicenter, double-blind, investigator-initiated clinical trial aimed to evaluate safety and efficacy of two ticagrelor-based de-escalation antiplatelet strategies in patients with acute coronary syndrome (ACS). During the hospitalization due to ACS, participants will be randomized in a 1:1:1 ratio into one of three arms: low-dose ticagrelor with aspirin (LDTA), low-dose ticagrelor with placebo (LDTP), and standard-dose ticagrelor with aspirin (SDTA), the latter being the control arm. Up to day 30, all enrolled patients will receive standard-dose ticagrelor (2x90mg) + aspirin (1x100mg). Starting from day 31 LDTA and LDTP patients will receive low-dose ticagrelor (2x60mg) + aspirin (1x100mg), SDTA - continuation of previous treatment. Starting from day 91 LDTP patients will receive low-dose ticagrelor (2x60mg) + placebo, SDTA and LDTA - continuation of previous treatment. The aim of the study is to evaluate the influence of ticagrelor maintenance dose reduction from 2x90mg to 2x60mg with or without continuation of aspirin versus dual antiplatelet therapy with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
for patients with NSTEMI or unstable angina, at least two of the following three criteria will have to be met:
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with ACS in this arm will be subject to reduction of ticagrelor maintenance dose from 2x90mg to 2x60mg after the first month post-ACS, and will receive the following antiplatelet therapy: 1. ticagrelor 2x90mg + aspirin 1x100mg during the first 30 days after ACS; 2. ticagrelor 2x60mg + aspirin 1x100mg starting from day 31 until 12 months after ACS.
Drug: Ticagrelor 60mg · Drug: Aspirin
Patients with ACS in this arm will be subject to reduction of ticagrelor maintenance dose from 2x90mg to 2x60mg after the first month post-ACS, followed by discontinuation of aspirin after 3 months post-ACS, and will receive the following antiplatelet therapy: 1. ticagrelor 2x90mg + aspirin 1x100mg during the first 30 days after ACS; 2. ticagrelor 2x60mg + aspirin 1x100mg starting from day 31 until day 90 after ACS; 3. ticagrelor 2x60mg + placebo starting from day 91 until 12 months after ACS.
Drug: Ticagrelor 60mg
Patients with ACS in this arm will receive standard dual antiplatelet therapy including ticagrelor 2x90mg + aspirin 1x100mg during the whole 12 months after ACS.
Drug: Ticagrelor 90mg · Drug: Aspirin
Up to day 30 after ACS, all enrolled patients will receive standard-dose ticagrelor 2x90mg as a part of dual antiplatelet therapy. Participants in SDTA arm will continue treatment with ticagrelor 2x90mg until 12 months post-ACS, while patients in LDTA and LDTP will be switched to low-dose ticagrelor 2x60 mg starting on day 31.
Also known as: Brilique
Starting from day 31, LDTA and LDTP patients will receive low-dose ticagrelor 2x60mg until 12 months post-ACS.
Also known as: Brilique
Up to day 90 after ACS, all enrolled patients will receive aspirin 1x100mg as a part of dual antiplatelet therapy. Starting from day 91, LDTP patients will discontinue aspirin and proceed with low-dose ticagrelor monotherapy until 12 months post-ACS, while patients in LDTA and SDTA will continue aspirin 1x100 mg until 12 months post-ACS.
Also known as: acetylsalicylic acid
BARC type 2, 3 or 5 bleeding
The primary safety composite end point of this study is the first occurrence of type 2, 3 or 5 bleeding according to the BARC criteria, occurring during the first 12 months after ACS.
Time frame: 12 months after ACS
Death from any cause, nonfatal MI or nonfatal stroke.
The primary efficacy end point is the composite of death from any cause, first nonfatal MI, or first nonfatal stroke.
Time frame: 12 months after ACS
Death from any cause, nonfatal MI, nonfatal stroke, BARC type 2, 3, or 5 bleeding.
The key secondary endpoint, net clinical effect, was defined as composite of death from any cause, nonfatal MI, or nonfatal stroke, and the first occurrence of BARC type 2, 3, or 5 bleeding.
Time frame: 12 months after ACS
BARC type 3 or 5 bleeding
Composite of the first occurrence of type 3 or 5 bleeding according to the BARC criteria.
Time frame: 12 months after ACS
TIMI major or minor bleeding
Composite of the first occurrence of major or minor bleeding according to the TIMI criteria.
Time frame: 12 months after ACS
GUSTO moderate, severe, or life-threatening bleeding
Composite of the first occurrence of moderate, severe, or life-threatening bleeding according to the GUSTO criteria.
Time frame: 12 months after ACS
ISTH major bleeding
The first occurrence of major bleeding according to the ISTH criteria.
Time frame: 12 months after ACS
Death from any cause
Death from any cause.
Time frame: 12 months after ACS
Death from cardiovascular causes
Death from cardiovascular causes.
Time frame: 12 months after ACS
Myocardial infarction
Occurrence of myocardial infarction.
Time frame: 12 months after ACS
Ischemic stroke
Occurrence of ischemic stroke.
Time frame: 12 months after ACS
Definite or probable stent thrombosis
Occurrence of definite or probable stent thrombosis
Time frame: 12 months after ACS
Dyspnea
Occurrence of dyspnea
Time frame: 12 months after ACS
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ticagrelor · Aspirin
ST Elevation Myocardial Infarction →
Collegium Medicum w Bydgoszczy