Coronary Artery DiseasePhase 3PL-PLATELETNCT03078465
Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI
A Phase 3 study testing Ticagrelor and Clopidogrel in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
To determine the safety and efficacy of Ticagrelor versus Clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ticagrelor and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2017to 30 May 2021
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who agreed to the experimental plan which was permitted by IRB;
- Patients planned to take dual antiplatelet therapy for 12 months.
Who cannot join
- Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit;
- Renal dysfunction defined as eGFR < 30ml/min/1.73m^2;
- Co-morbidity with an estimated life expectancy of < 50 % at 12 months;
- Scheduled surgery in the next 12 months, which resulted protocol changes;
- Known allergy against study drug or device;
- Use of glycoprotein IIb/IIIa inhibitor during the perioperative period;
- Anticoagulation treatment including warfarin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After Percutaneous Coronary Intervention: The PL-PLATELET Randomized Trial
To determine the safety and efficacy of Ticagrelor versus Clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.
Read the detailed description
This is a multi-center, randomized, single-blind, investigator-initiated study with a parallel design. Patients with coronary artery disease undergoing percutaneous coronary intervention and presenting high platelet reactivity on clopidogrel as assessed with the PL-11 analyzer (platelet maximum aggregation ratio [MAR%] ≥ 55 %) at 2 hours post-clopidogrel 300mg LD (Day 0), will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:
Group Α: Ticagrelor 180 mg immediate loading (on Day 0) followed by 180mg/day starting from Day 1 until Day 365 (12 months after randomization).
Group Β: Clopidogrel 150mg per day, starting from Day 1 until Day 365 (12 months after randomization).
Platelet reactivity assessment will be performed before randomization (Day 0), and 3-day after randomization (Day 3). Documentation of major adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events) will be performed until 12 months.
- Conditions
- Coronary Artery Disease
- Being tested
- Ticagrelor, Clopidogrel
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called BRILINTA
Daily administration of ticagrelor 180mg for 12 months
ClopidogrelDrug
Also called Plavix, Talcom
Daily administration of clopidogrel 150mg for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | Administration of ticagrelor 180mg/day for 12 months. Receives: Drug: Ticagrelor |
| Clopidogrel | Active comparator | Administration of clopidogrel 150 mg/day for 12 months Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-Month Freedom From MACE
Major adverse cardiovascular and cerebrovascular events consist of all-cause death, target vessel myocardial infarction, stroke, stent thrombosis.
Measured: 12 months
Secondary outcomes (7)
12-Month Freedom From Mortality
All-cause death
Measured: 12 months
12-Month Freedom From Cardiac death
Cardiac death
Measured: 12 months
12-Month Freedom From MI
Myocardial infarction
Measured: 12 months
12-Month Freedom From TLR
Target lesion revascularisation
Measured: 12 months
12-Month Freedom From TVR
Target vessel revascularisation
Measured: 12 months
12-Month Freedom From Stent Thrombosis
Stent thrombus was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC).Regarding timing, ST was defined as early (<30 days), late (30 days to 1 year), or too late (>1 year).
Measured: 12 months
12-Month Freedom From Stroke
Stroke
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start20 Jun 2017
- Primary completion30 May 2021 (estimated)
- Study completion30 May 2021 (estimated)
Why it stopped: Competitive studies were conducted at the same time, and enrollment was suspended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shao-Liang Chen, MD, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078465
- Sponsor's protocol ID
- NFH20170307
- Acronym
- PL-PLATELET
- Status last verified
- Aug 2021
- First submitted
- 7 Mar 2017
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang JJ, Gao XF, Ge Z, Tian NL, Liu ZZ, Lin S, Ye F, Chen SL. High platelet reactivity affects the clinical outcomes of patients undergoing percutaneous coronary intervention. BMC Cardiovasc Disord. 2016 Nov 29;16(1):240. doi: 10.1186/s12872-016-0394-0.
PubMed 27894260
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After Percutaneous Coronary Intervention: The PL-PLATELET Randomized Trial
- ClinicalTrials.gov ID
- NCT03078465
- Acronym / sponsor ID
- PL-PLATELET / NFH20170307
- Conditions
- Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Competitive studies were conducted at the same time, and enrollment was suspended.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy of Ticagrelor versus Clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.
Detailed description
This is a multi-center, randomized, single-blind, investigator-initiated study with a parallel design. Patients with coronary artery disease undergoing percutaneous coronary intervention and presenting high platelet reactivity on clopidogrel as assessed with the PL-11 analyzer (platelet maximum aggregation ratio [MAR%] ≥ 55 %) at 2 hours post-clopidogrel 300mg LD (Day 0), will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:
Group Α: Ticagrelor 180 mg immediate loading (on Day 0) followed by 180mg/day starting from Day 1 until Day 365 (12 months after randomization).
Group Β: Clopidogrel 150mg per day, starting from Day 1 until Day 365 (12 months after randomization).
Platelet reactivity assessment will be performed before randomization (Day 0), and 3-day after randomization (Day 3). Documentation of major adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events) will be performed until 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: TicagrelorAdministration of ticagrelor 180mg/day for 12 months. |
| Clopidogrel | Active comparator | Drug: ClopidogrelAdministration of clopidogrel 150 mg/day for 12 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who agreed to the experimental plan which was permitted by IRB;
- Patients planned to take dual antiplatelet therapy for 12 months.
Key exclusion criteria (7 listed)
- Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit;
- Renal dysfunction defined as eGFR < 30ml/min/1.73m^2;
- Co-morbidity with an estimated life expectancy of < 50 % at 12 months;
- Scheduled surgery in the next 12 months, which resulted protocol changes;
- Known allergy against study drug or device;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: BRILINTADaily administration of ticagrelor 180mg for 12 months | Drug | Ticagrelor |
| ClopidogrelAlso: Plavix, TalcomDaily administration of clopidogrel 150mg for 12 months | Drug | Clopidogrel |
Primary outcome
12-Month Freedom From MACE
Time frame: 12 months
Major adverse cardiovascular and cerebrovascular events consist of all-cause death, target vessel myocardial infarction, stroke, stent thrombosis.
7 secondary outcomes
12-Month Freedom From Mortality
Time frame: 12 months
12-Month Freedom From Cardiac death
Time frame: 12 months
12-Month Freedom From MI
Time frame: 12 months
12-Month Freedom From TLR
Time frame: 12 months
12-Month Freedom From TVR
Time frame: 12 months
12-Month Freedom From Stent Thrombosis
Time frame: 12 months
12-Month Freedom From Stroke
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Background: PubMed 27894260Zhang JJ, Gao XF, Ge Z, Tian NL, Liu ZZ, Lin S, Ye F, Chen SL. High platelet reactivity affects the clinical outcomes of patients undergoing percutaneous coronary intervention. BMC Cardiovasc Disord. 2016 Nov 29;16(1):240. doi: 10.1186/s12872-016-0394-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shao-Liang Chen, MD study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor and Clopidogrel in people with Coronary Artery Disease, 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 19 Aug 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
12-Month Freedom From MACE (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 NCT03078465, which also lists 1 linked publication.
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 19 Aug 2021.