Trial · NCT03822377

Ticagrelor Administered as Standard Tablet or Orodispersible Formulation

NCT03822377, Phase 3, Completed, Azienda Ospedaliero Universitaria di Sassari; results first posted 2021-09-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ticagrelor Administered as Standard Tablet or Orodispersible Formulation. Trials, record NCT03822377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03822377

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ticagrelor Administered as Standard Tablet or Orodispersible Formulation
NCT number: NCT03822377
Status: Completed
Phases: Phase 3
Enrollment: 130 participants, actual
Lead sponsor: Azienda Ospedaliero Universitaria di Sassari
Conditions: ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI
Interventions: Ticagrelor orodispersible tablets, Ticagrelor standard tablets
First posted: 2019-01-30
Last updated: 2021-09-08
Other registries' IDs: eudract:2018-001790-25
Results first posted: 2021-09-08

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Evaluation of Platelet Inhibition	1 hour	Platelet reactivity will be measured by VerifyNow test 1 hour after Ticagrelor loading dose (LD) administered as orodispersible tablets as compared with standard formulation in 130 patients with STEMI or very high-risk NSTEMI undergoing immediate PCI. The VerifyNow PRU Test is designed to measure P2Y12 receptor blockade. Results of the PRU Tests are reported as P2Y12 Reaction Units (PRU). PRU measures the extent of platelet aggregation in the presence of a P2Y12 inhibitor. Lower PRU levels are associated with expected antiplatelet effect.
Secondary	Percent of Patients With Insufficient Antiaggregation	1 hour	The percent of patients with a high residual platelet reactivity (PRU \> 208 by VerifyNow test), thus not adequately antiaggregated, 1 hour after Ticagrelor LD.
Secondary	Number of Participants With Residual Platelet Reactivity at Various Timepoints	2, 4 and 6 hours	Residual platelet reactivity (PRU) at 2, 4 and 6 hours measured by VerifyNow test to assess antiplatelet effect of P2Y12 inhibitors
Secondary	Number of Participants With Clinically Relevant Bleeding Events	30 days	Actionable bleeding events across the two different regimens of Ticagrelor administration, requiring diagnostic studies, hospitalization, or treatment by a health care professional (BARC type 2 or higher)
Other	Number of Participants With Morphine-ticagrelor Interaction	6 hours	Potential morphine-ticagrelor interaction will be assessed by stratified randomization according to morphine use
Other	Incidence of Adverse Events Occurring During Hospital Stay	Until discharge from the hospital (usually up to 7 days)	Combined ticagrelor administration-related adverse events defined as in-hospital ≥2 BARC bleedings, dyspnea, ventricular pauses, allergic reactions, or vomit

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Evaluation of Platelet Inhibition	1 hour	P2Y12 Reaction Units (PRU)	MEDIAN
SECONDARY	Percent of Patients With Insufficient Antiaggregation	1 hour	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Residual Platelet Reactivity at Various Timepoints	2, 4 and 6 hours	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinically Relevant Bleeding Events	30 days	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With Morphine-ticagrelor Interaction	6 hours	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Incidence of Adverse Events Occurring During Hospital Stay	Until discharge from the hospital (usually up to 7 days)	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Evaluation of Platelet Inhibition	Ticagrelor Orodispersible Tablets	94	Inter-Quartile Range 35 to 193	P2Y12 Reaction Units (PRU)
Evaluation of Platelet Inhibition	Ticagrelor Standard Tablets	141	Inter-Quartile Range 8 to 197	P2Y12 Reaction Units (PRU)
Percent of Patients With Insufficient Antiaggregation	Experimental Arm	51		Participants
Percent of Patients With Insufficient Antiaggregation	Control Arm	53		Participants
Number of Participants With Residual Platelet Reactivity at Various Timepoints	Ticagrelor Orodispersible Tablets	42		Participants
Number of Participants With Residual Platelet Reactivity at Various Timepoints	Ticagrelor Standard Tablets	9		Participants
Number of Participants With Clinically Relevant Bleeding Events	Ticagrelor Orodispersible Tablets	0		Participants
Number of Participants With Clinically Relevant Bleeding Events	Ticagrelor Standard Tablets	4		Participants
Number of Participants With Morphine-ticagrelor Interaction	Ticagrelor Orodispersible Tablets	6		Participants
Number of Participants With Morphine-ticagrelor Interaction	Ticagrelor Standard Tablets	4		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ticagrelor Orodispersible Tablets	65
Overall Study	STARTED	Ticagrelor Standard Tablets	65
Overall Study	COMPLETED	Ticagrelor Orodispersible Tablets	65
Overall Study	COMPLETED	Ticagrelor Standard Tablets	65
Overall Study	NOT COMPLETED	Ticagrelor Orodispersible Tablets	0
Overall Study	NOT COMPLETED	Ticagrelor Standard Tablets	0

Source ClinicalTrials.gov

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Combined ticagrelor administration-related adverse events defined as in-hospital ≥2 BARC bleedings,	Cardiac disorders	Ticagrelor Orodispersible Tablets	14	65
other	Combined ticagrelor administration-related adverse events defined as in-hospital ≥2 BARC bleedings,	Cardiac disorders	Ticagrelor Standard Tablets	15	65
serious	Reinfarction	Cardiac disorders	Ticagrelor Orodispersible Tablets	1	65
serious	Reinfarction	Cardiac disorders	Ticagrelor Standard Tablets	0	65

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ticagrelor Orodispersible Tablets	0	65
Total, all-cause mortality	Ticagrelor Standard Tablets	0	65
Total, other adverse events	Ticagrelor Orodispersible Tablets	14	65
Total, other adverse events	Ticagrelor Standard Tablets	15	65
Total, serious adverse events	Ticagrelor Orodispersible Tablets	1	65
Total, serious adverse events	Ticagrelor Standard Tablets	0	65

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34266583	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Experimental Arm vs Control Arm: Percent of Patients With Insufficient Antiaggregation	Trial comparisons
Experimental Arm vs Control Arm: Incidence of Adverse Events Occurring During Hospital Stay	Trial comparisons
Ticagrelor Orodispersible Tablets vs Ticagrelor Standard Tablets: Number of Participants With Residual Platelet Reactivity at Various Timepoints	Trial comparisons
Ticagrelor Orodispersible Tablets vs Ticagrelor Standard Tablets: Number of Participants With Morphine-ticagrelor Interaction	Trial comparisons
Ticagrelor Orodispersible Tablets vs Ticagrelor Standard Tablets: Number of Participants With Clinically Relevant Bleeding Events	Trial comparisons
Ticagrelor Orodispersible Tablets vs Ticagrelor Standard Tablets: deaths from any cause	Trial comparisons
Ticagrelor Orodispersible Tablets vs Ticagrelor Standard Tablets: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03822377

GET https://conductscience.org/api/trials/v1/NCT03822377/registered

API reference For AI assistants