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ThrombosisPhase 4NCT02140801

Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel

A Phase 4 study testing Ticagrelor and Clopidogrel in people with Thrombosis, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A number of 352 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either BRILINTA™ (ticagrelor) or Plavix® (clopidogrel bisulfate). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thrombosis
What is being tested?
Ticagrelor and Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
1 siteChina
Study dates
1 May 2014to 8 Mar 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent prior to any study specific procedures;
  • Men and women 18 years and older;.
  • Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;
  • Native coronary lesion suitable for drug-eluting stent placement and OCT imaging.

Who cannot join

  • Pregnancy and breast feeding mother;
  • Co-morbidity with an estimated life expectancy of < 50 % at 12 months;
  • Scheduled major surgery in the next 6 months;
  • Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
  • Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days
  • Cardiogenic shock
Show all 22Show fewer
  • Previous subacute or late coronary stent thrombosis
  • Known allergy against ticagrelor, or against clopidogrel, or aspirin
  • History of major hemorrhage (intracranial, gastrointestinal, etc.)
  • Active pathological bleeding
  • Acute or chronic hematologic disorder including a Hemoglobin less than 10 g/L or a platelet count less than 10×109/L before procedure
  • Any history of Severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension and active hepatitis);
  • Neutropenia,
  • thrombocytopenia;
  • Known acute pancreatitis
  • Arterial aneurysm, arterial/venous malformation and aorta dissection.
  • Culprit lesion within the proximal 10 mm of the right or left coronary artery
  • Saphenous vein grafts
  • Lesion length > 30 mm
  • Involves a side branch ≥2.0 mm in diameter by visual estimate which requires treatment
  • In-stent restenotic lesions
  • Thombus-containing lesions

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

Other trials in China

About this study

Official title: A Randomised, Open-label, Parallel Group, Multi-center Study Using OCT to Comparing the Efficacy and Safety of Ticagrelor With Clopidogrel in the Prevention of Subclinical Thrombus in Patients After Drug-eluting Stent Implantation

A number of 352 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either BRILINTA™ (ticagrelor) or Plavix® (clopidogrel bisulfate).

Read the detailed description

The study is prospectively conducted at 4 high-volume PCI center in China with OCT expertise. Angiographic follow-up and OCT imaging with motorized pull-back at 20-36 mm/s are planned in all patients 12 months after implantation of the study stents. OCT endpoints are: (1) Subclinical intra-stent thrombus, defined as a mass protruding to the lumen with significant attenuation, and respectively (2) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts. The study is powered for OCT endpoints, which are likely to reach significance at the level P < 0.05 even at a follow-up drop-out rate up to 10%.

Conditions
Thrombosis
Being tested
Ticagrelor, Clopidogrel
Keywords
Percutaneous coronary intervention, Drug-eluting stent, Thrombosis
Medical subject headings
Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TicagrelorDrug

    Also called BRILINTA™

    Plain, round, yellow, filmcoated tablet, 90 mg

  • ClopidogrelDrug

    Also called Plavix®

    Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)

Study groups in NCT02140801
Study groupRoleWhat they receive
TicagrelorExperimentalTicagrelor 90mg tablet, twice daily
Receives: Drug: Clopidogrel
ClopidogrelExperimentalClopidogrel 75mg tablet, daily
Receives: Drug: Ticagrelor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subclinical thrombus

    The occurrence of subclinical thrombus as detected by OCT

    Measured: 12 months

Secondary outcomes (4)

  1. Endothelial coverage of the stent struts assessed by optical coherence tomography

    Measured: 12 months

  2. Neointimal proliferation within the stent assessed by optical coherence tomography

    Measured: 12 months

  3. Stent malposition assessed by optical coherence tomography

    Measured: 12 months

  4. Edge dissections assessed by optical coherence tomography

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2014 (estimated)
  2. Study start1 May 2014
  3. Primary completion8 Mar 2017
  4. Study completion8 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02140801
Sponsor's protocol ID
ISSBRIL0361
Status last verified
Mar 2018
First submitted
14 May 2014
Last updated
21 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu Y, Wang YF, Zhao MY, You W, Xu T, Meng PN, Wu XQ, Wu ZM, Kong XH, Yin DL, Zhan ME, Jia HB, Liu B, Ye F. Study on the potential clinical significance of subclinical stent edge effects after drug-eluting stent implantation. Sci Rep. 2025 Mar 10;15(1):8258. doi: 10.1038/s41598-024-81329-7.

    PubMed 40064903

  • Nong JC, You W, Wang YF, Xu Y, Xu T, Meng PN, Wu XQ, Wu ZM, Kong XH, Jia HB, Yin DL, Li L, Ye F. Dynamic natural components and morphological changes in nonculprit subclinical atherosclerosis in patients with acute coronary syndrome and mild chronic kidney disease at the 1-year follow-up and clinical significance at the 5-year follow-up. PLoS One. 2024 May 31;19(5):e0302547. doi: 10.1371/journal.pone.0302547. eCollection 2024.

    PubMed 38820294

  • Meng PN, Nong JC, Xu Y, You W, Xu T, Wu XQ, Wu ZM, Tao BL, Guo YJ, Yin DL, Jia HB, Yang S, Ye F. Morphologies and composition changes in nonculprit subclinical atherosclerosis in diabetic versus nondiabetic patients with acute coronary syndrome who underwent long-term statin therapy. Sci Rep. 2023 Apr 1;13(1):5338. doi: 10.1038/s41598-023-32638-w.

    PubMed 37005448

  • Nong JC, You W, Xu T, Meng PN, Xu Y, Wu XQ, Wu ZM, Tao BL, Guo YJ, Yang S, Yin DL, Ye F. Dynamic natural morphologies and component changes in nonculprit subclinical atherosclerosis in patients with acute coronary syndrome at 1-year follow-up and clinical significance at 3-year follow-up. Atherosclerosis. 2022 Sep;356:1-8. doi: 10.1016/j.atherosclerosis.2022.07.013. Epub 2022 Jul 31.

    PubMed 35939981

  • Wu X, You W, Wu Z, Wu Q, Jiang J, Yan H, Ye F, Chen S. Ticagrelor versus clopidogrel for prevention of subclinical stent thrombosis detected by optical coherence tomography in patients with drug-eluting stent implantation-a multicenter and randomized study. Platelets. 2021 Apr 3;32(3):404-412. doi: 10.1080/09537104.2020.1754381. Epub 2020 Apr 24.

    PubMed 32326796

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor and Clopidogrel in people with Thrombosis, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subclinical thrombus (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02140801, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.

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