Trial · NCT03381742
Efficacy and Safety of Low-dose Ticagrelor
NCT03381742, Phase 2, Phase 3, Completed, First Affiliated Hospital of Harbin Medical University; results first posted 2019-09-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Low-dose Ticagrelor. Trials, record NCT03381742. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03381742
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Low-dose Ticagrelor
- NCT number
- NCT03381742
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 3,043 participants, actual
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Conditions
- Coronary Artery Disease
- Interventions
- Ticagrelor, ticagrelor, ticagrelor, clopidogrel
- First posted
- 2017-12-22
- Last updated
- 2019-09-30
- Results first posted
- 2019-09-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ADP-induced Inhibition of Platelet Aggregation | up to 5 days | The venous blood samples for platelet function test were drawn after an overnight fast, at 12 hours post-last study-drug dose for subjects receiving twice-daily administrations, and at 24 hours post-last study-drug dose for subjects treated with once-daily regimens. The blood was collected in an evacuated vacuum tube containing 3.2% trisodium citrate and lithium heparin. Then the samples were processed within two hours of blood draw according to standard operating procedure. The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced inhibition of platelet aggregation (IPA, range 0% - 100%), with higher values indicating greater platelet inhibition. |
| Primary | Number of Participants With Bleeding (Major or Minor Bleeding) | up to 5 days | Major bleeding was defined as type ≥ 3 and minor bleeding as types 1 and 2, in accordance to the Bleeding Academic Research Consortium classification. (Mehran R et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449.) |
| Secondary | ADP-induced Platelet-fibrin Clot Strength (MA) | up to 5 days | The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced platelet-fibrin clot strength (MA). A MA\>47mm was shown to have a high predictive value for 3-year post-PCI ischemic events during dual antiplatelet therapy. Moreover, ROC curve and quartile analysis suggested MA\<31 mm as a predictive value for post-PCI bleeding events (J Am Coll Cardiol. 2013;62(24):2261-73. doi: 10.1016/j.jacc.2013.07.101.). |
| Secondary | Number of Participants With High On-Treatment Platelet Reactivity (HTPR) | up to 5 days | HTPR was defined as IPA ≤ 30% and MA ≥ 47 mm. |
| Secondary | Number of Participants With Cardiovascular Event (Cardiovascular Death, New-onset Myocardial Infarction, or Stroke) | up to 5 days | Cardiovascular death was defined as sudden cardiac death, fatal myocardial infarction, death due to heart failure, or death due to other cardiovascular causes. Stroke was defined as the focal loss of neurologic function caused by an ischemic or a hemorrhagic event with residual symptoms lasting at least 24 hours or eventually leading to death. |
| Secondary | Number of Participants With New-onset Dyspnea | up to 5 days | New-onset dyspnea in patients without previous history of dyspnea |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ADP-induced Inhibition of Platelet Aggregation | up to 5 days | percentage of inhibition of platelet agg | MEDIAN | |
| PRIMARY | Number of Participants With Bleeding (Major or Minor Bleeding) | up to 5 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | ADP-induced Platelet-fibrin Clot Strength (MA) | up to 5 days | mm | MEDIAN | |
| SECONDARY | Number of Participants With High On-Treatment Platelet Reactivity (HTPR) | up to 5 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Cardiovascular Event (Cardiovascular Death, New-onset Myocardial Infarction, or Stroke) | up to 5 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With New-onset Dyspnea | up to 5 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ADP-induced Inhibition of Platelet Aggregation | Clopidogrel 75mg Qdpo. | 54.9 | Inter-Quartile Range 31.9 to 79.1 | percentage of inhibition of platelet agg | |
| ADP-induced Inhibition of Platelet Aggregation | Ticagrelor 90mg Bidpo. | 80.6 | Inter-Quartile Range 64.1 to 94 | percentage of inhibition of platelet agg | |
| ADP-induced Inhibition of Platelet Aggregation | Ticagrelor 45mg Bidpo. | 73.6 | Inter-Quartile Range 52.6 to 93.7 | percentage of inhibition of platelet agg | |
| ADP-induced Inhibition of Platelet Aggregation | Ticagrelor 90mg Qdpo. | 66 | Inter-Quartile Range 46.9 to 87 | percentage of inhibition of platelet agg | |
| Number of Participants With Bleeding (Major or Minor Bleeding) | Clopidogrel 75mg Qdpo. | Minor bleeding | 15 | Participants | |
| Number of Participants With Bleeding (Major or Minor Bleeding) | Ticagrelor 90mg Bidpo. | Minor bleeding | 30 | Participants | |
| Number of Participants With Bleeding (Major or Minor Bleeding) | Ticagrelor 45mg Bidpo. | Minor bleeding | 14 | Participants | |
| Number of Participants With Bleeding (Major or Minor Bleeding) | Ticagrelor 90mg Qdpo. | Minor bleeding | 9 | Participants | |
| Number of Participants With Bleeding (Major or Minor Bleeding) | Clopidogrel 75mg Qdpo. | Major bleeding | 0 | Participants | |
| Number of Participants With Bleeding (Major or Minor Bleeding) | Ticagrelor 90mg Bidpo. | Major bleeding | 0 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ticagrelor 45mg Bidpo. | 525 | |
| Overall Study | STARTED | Ticagrelor 90mg Bidpo. | 501 | |
| Overall Study | STARTED | Clopidogrel 75mg Qdpo. | 1,511 | |
| Overall Study | STARTED | Ticagrelor 90mg Qdpo. | 506 | |
| Overall Study | COMPLETED | Ticagrelor 45mg Bidpo. | 525 | |
| Overall Study | COMPLETED | Ticagrelor 90mg Bidpo. | 501 | |
| Overall Study | COMPLETED | Clopidogrel 75mg Qdpo. | 1,511 | |
| Overall Study | COMPLETED | Ticagrelor 90mg Qdpo. | 506 | |
| Overall Study | NOT COMPLETED | Ticagrelor 45mg Bidpo. | 0 | |
| Overall Study | NOT COMPLETED | Ticagrelor 90mg Bidpo. | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clopidogrel 75mg Qdpo. | 0 | 1,511 |
| Total, all-cause mortality | Ticagrelor 90mg Bidpo. | 0 | 501 |
| Total, all-cause mortality | Ticagrelor 45mg Bidpo. | 0 | 525 |
| Total, all-cause mortality | Ticagrelor 90mg Qdpo. | 0 | 506 |
| Total, other adverse events | Clopidogrel 75mg Qdpo. | 0 | 1,511 |
| Total, other adverse events | Ticagrelor 90mg Bidpo. | 0 | 501 |
| Total, other adverse events | Ticagrelor 45mg Bidpo. | 0 | 525 |
| Total, other adverse events | Ticagrelor 90mg Qdpo. | 0 | 506 |
| Total, serious adverse events | Clopidogrel 75mg Qdpo. | 0 | 1,511 |
| Total, serious adverse events | Ticagrelor 90mg Bidpo. | 0 | 501 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT03381742
GET https://conductscience.org/api/trials/v1/NCT03381742/results?page=2