A Phase 2/3 interventional study of Ticagrelor and ticagrelor in Coronary Artery Disease, sponsored by First Affiliated Hospital of Harbin Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by First Affiliated Hospital of Harbin Medical University · Phase 2/3, Interventional, and Treatment
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Among 78 studies testing ticagrelor in Coronary Artery Disease — 5 open to participants now, 5 under way, 2 of them phase 3. Ticagrelor · Coronary Artery Disease.
Among the 78 studies testing ticagrelor in Coronary Artery Disease, this one is the 4th largest by enrollment, is one of 9 that started in 2017, is one of 5 in phase 2/3, and was the 56th registered.
4,861 studies on the registry are indexed under Coronary Artery Disease; 892 are open to participants now.
Browse Coronary Artery Disease studies →5 of the 78 studies testing ticagrelor in Coronary Artery Disease are open now, in 5 countries. Recruiting first, the newest first:
Cardiocentro Ticino · Sites in Switzerland
Ages 18+
Shiraz University of Medical Sciences · Sites in Iran, Islamic Republic of
Ages 20–80
University of Florida · Sites in United States
Ages 18+
St. Antonius Hospital · Sites in Netherlands
Ages 18+
Campus Bio-Medico University · Sites in Italy
Ages 18+
By country, each count listing its studies:
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 588 Coronary Artery Disease studies recruiting now, 403 (69%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
78 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 12 · Phase 3 18 · Phase 4 46
First in 2006; this study’s year is marked. 9 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3,043 is above the median of 124 across 3,009 interventional studies indexed under Coronary Artery Disease.
Median enrollment 80 across the 78 interventional studies. Of the 59 that completed or were terminated, 26 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 78 have an industry lead sponsor. The 10 most frequent:
First Affiliated Hospital of Harbin Medical University is the lead sponsor of 74 studies on the registry; 11 are open to participants now.
First Affiliated Hospital of Harbin Medical University has 8 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
1 of the studies testing ticagrelor in Coronary Artery Disease that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06228456University of FloridaEffects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention | 2026-12-31 |
Add it to your calendar (.ics) → With an account.
Among the 78 studies testing ticagrelor in Coronary Artery Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But large-scale clinical trials are still needed to confirm the effects of low-dose ticagrelor on platelet function in Chinese patients with coronary heart disease.
Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor.
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But large-scale clinical trials are still needed to confirm the effects of low-dose ticagrelor on platelet function in Chinese patients with coronary heart disease.
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.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease.
Drug: Ticagrelor
To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease.
Drug: ticagrelor
To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease.
Drug: ticagrelor
To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease.
Drug: clopidogrel
ticagrelor 45 mg twice daily for 5 consecutive days at least.
ticagrelor 90 mg once daily for 5 consecutive days at least.
ticagrelor 90 mg twice daily for 5 consecutive days at least.
clopidogrel 75 mg once daily for 5 consecutive days at least.
ADP-induced Inhibition of Platelet Aggregation
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.
Time frame: up to 5 days
Number of Participants With Bleeding (Major or Minor Bleeding)
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.)
Time frame: up to 5 days
ADP-induced Platelet-fibrin Clot Strength (MA)
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.).
Time frame: up to 5 days
Number of Participants With High On-Treatment Platelet Reactivity (HTPR)
HTPR was defined as IPA ≤ 30% and MA ≥ 47 mm.
Time frame: up to 5 days
Number of Participants With Cardiovascular Event (Cardiovascular Death, New-onset Myocardial Infarction, or Stroke)
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.
Time frame: up to 5 days
Number of Participants With New-onset Dyspnea
New-onset dyspnea in patients without previous history of dyspnea
Time frame: up to 5 days
3,737 CAD patients who received either clopidogrel or ticagrelor therapy and underwent TEG test from 11 medical centers. Among these patients, 1,725 subjects were treated with clopidogrel and 2,012 subjects were treated with different ticagrelor regimens.
| Milestone | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Bidpo. | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Qdpo. |
|---|---|---|---|---|
| Started | 525 | 501 | 1511 | 506 |
| Completed | 525 | 501 | 1511 | 506 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| percentage of inhibition of platelet agg | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. |
|---|---|---|---|---|
| ADP-induced Inhibition of Platelet Aggregation | 54.9 (31.9 to 79.1) | 80.6 (64.1 to 94) | 73.6 (52.6 to 93.7) | 66 (46.9 to 87) |
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.)
| Participants | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. |
|---|---|---|---|---|
| Minor bleeding | 15 | 30 | 14 | 9 |
| Major bleeding | 0 | 0 | 0 | 0 |
| No bleeding | 1496 | 471 | 511 | 497 |
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.).
| mm | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. |
|---|---|---|---|---|
| ADP-induced Platelet-fibrin Clot Strength (MA) | 40.3 (27 to 51.6) | 28.4 (18.5 to 38.9) | 32.3 (19.5 to 43.9) | 34.05 (23.6 to 46.1) |
HTPR was defined as IPA ≤ 30% and MA ≥ 47 mm.
| Participants | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. |
|---|---|---|---|---|
| HTPR | 317 | 13 | 23 | 32 |
| Non-HTPR | 1194 | 488 | 502 | 474 |
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.
| Participants | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. |
|---|---|---|---|---|
| Participants with cardiovascular death | 0 | 0 | 0 | 0 |
| Participants without cardiovascular events | 1511 | 501 | 525 | 506 |
| Participants with new-onset myocardial infarction | 0 | 0 | 0 | 0 |
| Participants with stroke | 0 | 0 | 0 | 0 |
New-onset dyspnea in patients without previous history of dyspnea
| Participants | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. |
|---|---|---|---|---|
| Participants with new-onset dyspnea | 34 | 29 | 32 | 28 |
| Participants without new-onset dyspne | 1477 | 472 | 493 | 478 |
Collected over up to 5 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clopidogrel 75mg Qdpo. | 0/1,511 (0%) | 0/1,511 (0%) | 0/1,511 (0%) |
| Ticagrelor 90mg Bidpo. | 0/501 (0%) | 0/501 (0%) | 0/501 (0%) |
| Ticagrelor 45mg Bidpo. | 0/525 (0%) | 0/525 (0%) | 0/525 (0%) |
| Ticagrelor 90mg Qdpo. | 0/506 (0%) | 0/506 (0%) | 0/506 (0%) |
| Age, Continuous(years) | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. | Total |
|---|---|---|---|---|---|
| Median | 63 (55 to 69) | 61 (52 to 67) | 62 (55 to 69) | 62 (55 to 68) | 62 (55 to 69) |
| Sex: Female, Male(Participants) | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. | Total |
|---|---|---|---|---|---|
| Female | 532 | 159 | 201 | 237 | 1129 |
| Male | 979 | 342 | 324 | 269 | 1914 |
| Race (NIH/OMB)(Participants) | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 1511 | 501 | 525 | 506 | 3043 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. | Total |
|---|---|---|---|---|---|
| China | 1511 | 501 | 525 | 506 | 3043 |
| Weight(kg) | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. | Total |
|---|---|---|---|---|---|
| Median | 70 (63 to 78) | 70 (62 to 78) | 70 (60 to 75) | 70 (60 to 75) | 70 (62 to 78) |
| smoking(Participants) | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. | Total |
|---|---|---|---|---|---|
| Count of participants | 736 | 234 | 226 | 202 | 1398 |
| Hypertension(Participants) | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. | Total |
|---|---|---|---|---|---|
| Count of participants | 879 | 243 | 332 | 287 | 1741 |
| diabetes mellitus(Participants) | Clopidogrel 75mg Qdpo. | Ticagrelor 90mg Bidpo. | Ticagrelor 45mg Bidpo. | Ticagrelor 90mg Qdpo. | Total |
|---|---|---|---|---|---|
| Count of participants | 426 | 126 | 161 | 117 | 830 |
11 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Dec 2018, 12 months.
Results were first posted in Sep 2019, 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ticagrelor
First Affiliated Hospital of Harbin Medical University