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Coronary Artery DiseasePhase 4ESTNCT01700322

Endothelium, Stenting, and Antiplatelet Therapy (EST) - Clopidogrel, Prasugrel, Ticagrelor Study

A Phase 4 study testing Coronary stenting, Ticagrelor and Clopidogrel in people with Coronary Artery Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.

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

Endothelial dysfunction is an important predictor - and a determinant - of adverse clinical outcome. Endothelial function is impaired by coronary artery stenting, a stud from our group has shown that it can be improved by platelet inhibition using clopidogrel. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Coronary stenting, Ticagrelor and Clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteGermany
Study dates
Aug 2012to Sep 2016
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 18-75 years old consecutive patients undergoing coronary angiography and stenting at the University Medical Centre Mainz
  • A coronary lesion (and patient) amenable to treatment with drug eluting stent
  • Ability of subject to understand character and individual consequences of clinical trial
  • Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
  • Negative pregnancy test of women with childbearing potential

Who cannot join

  • Subjects presenting 1 or more of the following criteria will not be enrolled in the trial:
  • Patients with elevated (> 5 times upper normal limit) C-reactive protein level prior to stenting
  • Patients in whom therapy with long-acting nitrates cannot be suspended prior to endothelial function measurements
  • An acute coronary syndrome treated with coronary stenting within the last 4 weeks
  • Patients with known inflammatory/infective diseases
  • Patients with severe extracardiac diseases limiting life expectancy
Show all 22Show fewer
  • Known heart failure (LV-EF ≤ 40% AND NYHA III-IV)
  • PCI or coronary By-Pass surgery within the last 4 weeks, pre-existing ongoing treatment with any of the study treatments.
  • History of cerebrovascular events (stroke)
  • Known renal dysfunction (serum creatinine ≥ 1.8mg/dl in women, ≥ 2.0mg/dl in men)
  • Serum potassium > 5.5mmol/l
  • Known hepatic impairment (AST, ALT > 3 times upper limit of normal)
  • Changes in the ß-blocker, statin or ACE or angiotensin-receptor blocker inhibitor treatment within the past 2 weeks
  • Pregnancy and lactation, inadequate contraception
  • Body weight < 60kg
  • Active bleeding
  • Therapy with CYP3A4 inhibitors (ketoconazole, protease inhibitors, macrolide antibiotics)
  • Therapy with anticoagulants: phenprocoumone, warfarin, dabigatran, rivaroxaban
  • History of hypersensitivity to any of the investigational medicinal products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
  • Ongoing participation in other clinical trials or within the last 3 months, or ongoing therapy with one of the study medications.
  • Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
  • Patients with acute ST-elevation myocardial infarction

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • 2 Medical Clinic

    Mainz, 55131

Other trials in Germany

About this study

Official title: Effects of Clopidogrel vs Prasugel vs Ticagrelor on Endothelial Function, Inflammatory and Oxidative Stress Parameters and Platelet Function in Patients Undergoing Coronary Artery Stenting. A Randomised, Prospective Study.

Endothelial dysfunction is an important predictor - and a determinant - of adverse clinical outcome. Endothelial function is impaired by coronary artery stenting, a stud from our group has shown that it can be improved by platelet inhibition using clopidogrel. However, clopidogrel unresponsiveness is a known problem, and it has been show that the endothelial effects of clopidogrel tend to wane upon prolonged treatment. Whether a more effective anti-platelet therapy is able to prevent/improve not only thrombotic events but also endothelial dysfunction, with potential positive impact on clinical outcome in patients undergoing coronary artery stenting, is an important hypothesis that needs to be further investigated. To date, evidence regarding "ancillary" (non-platelet-dependent) effects of antiaggregant drugs is very limited. For instance, while their antiplatelet effects, and their beneficial effects in patients with acute coronary syndromes, have been clearly demonstrated in multicentric trials, it remains to be shown whether these drugs also protect endothelial function. Interestingly, some authors suggest that the mortality benefit observed in the PLATO study is at least in part independent of direct antiplatelet effects. No study, to date, has tested the effects of prasugrel and/or ticagrelor on endothelial function. With the present trial, the investigators plan to test the effect of clopidogrel, prasugrel and ticagrelor on endothelial function before and up to 4 weeks after coronary artery stenting. This study will provide important pathophysiologic insight on the relationship between platelet aggregation and endothelial function, two parameters that have been shown to influence patients' prognosis.

Being tested
Coronary stenting, Ticagrelor, Clopidogrel, Prasugrel
Keywords
Coronary artery disease, coronary stenting, platelet aggregation
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.

  • Coronary stentingProcedure or surgery

    All patients will receive a drug eluting stent as clinically indicated.

  • TicagrelorDrug

    Ticagrelor 180mg oral loading dose and 90mg b.i.d for 30 days following coronary artery stenting

  • ClopidogrelDrug

    Clopidogrel 600mg loading dose + 75 mg once a day for 30 days following coronary artery stenting.

  • PrasugrelDrug

    Prasugrel 60mg oral loading dose followed by 10mg once a day for 30 days following coronary artery stenting

Study groups in NCT01700322
Study groupRoleWhat they receive
TicagrelorActive comparatorTicagrelor 180mg oral loading dose and 90mg b.i.d for 30 days following coronary artery stenting
Receives: Procedure: Coronary stenting; Drug: Ticagrelor
ClopidogrelActive comparatorClopidogrel 600mg loading dose + 75 mg once a day for 30 days following coronary artery stenting.
Receives: Procedure: Coronary stenting; Drug: Clopidogrel
PrasugrelActive comparatorPrasugrel 60mg oral loading dose followed by 10mg once a day for 30 days following coronary artery stenting
Receives: Procedure: Coronary stenting; Drug: Prasugrel

What is being measured

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

  1. Change in FMD

    The primary endpoint is the change in flow-mediated dilation (FMD) (comparison before treatment versus after treatment and stenting) in the three study groups. The mean FMD across the three measurements (1 day, 1 week, 1 month) performed after coronary artery stenting will be compared to the FMD value before drug administration and stenting.

    Measured: baseline and 1 month

Secondary outcomes (4)

  1. FMD 2 hours after loading dose

    Change in FMD 2 hours after the administration of the study drug

    Measured: baseline and 2 hours after loading dose

  2. L-FMC at 2 hours after the loading dose

    change in L-FMC at two hours after the loading dose

    Measured: baseline and 2 hours

  3. L-FMC 1 month after loading dose

    change in flow-mediated constriction (L-FMC) (comparison before treatment versus after treatment and stenting) in the three study groups. The mean L-FMC across the three measurements (1 day, 1 week, 1 month) performed after coronary artery stenting will be compared to the value before drug administration and stenting

    Measured: baseline and 1 day after stenting

  4. Safety and tolerability

    Number of patients with adverse events.

    Measured: from baseline to 1 month after enrollment

Timeline

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

  1. First posted4 Oct 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJul 2016
  4. Study completionSep 2016

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01700322
Sponsor's protocol ID
CTH-C1
Acronym
EST
Status last verified
Sep 2016
First submitted
4 Sep 2012
Last updated
7 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Schnorbus B, Jurk K, Lackner KJ, Welk C, Munzel T, Gori T. Effects of Clopidogrel, Prasugrel and Ticagrelor on Microvascular Function and Platelet Reactivity in Patients With Acute Coronary Syndrome Undergoing Coronary Artery Stenting. A Randomized, Blinded, Parallel Group Trial. Front Cardiovasc Med. 2021 Dec 13;8:780605. doi: 10.3389/fcvm.2021.780605. eCollection 2021.

    PubMed 34966798

  • Schnorbus B, Daiber A, Jurk K, Warnke S, Konig J, Krahn U, Lackner K, Munzel T, Gori T. Effects of clopidogrel, prasugrel and ticagrelor on endothelial function, inflammatory and oxidative stress parameters and platelet function in patients undergoing coronary artery stenting for an acute coronary syndrome. A randomised, prospective, controlled study. BMJ Open. 2014 May 6;4(5):e005268. doi: 10.1136/bmjopen-2014-005268.

    PubMed 24801283

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Coronary stenting, Ticagrelor and Clopidogrel in people with Coronary Artery Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.

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 5 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 7 Sep 2016. 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 Germany. 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?

Change in FMD (time frame: baseline and 1 month). 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 NCT01700322, which also lists 2 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 7 Sep 2016.

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