Acute Myocardial InfarctionAnti-ClotNCT02051361
Antiplatelet Therapy Following Stent Implantation
An observational study of Acute Myocardial Infarction and Coronary Syndrome, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial summary
Coronary artery stents, particularly drug-eluting stents (DES), are used in the majority of patients who undergo percutaneous coronary intervention (PCI) to improve symptoms in patients with obstructive coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction, Coronary Syndrome, Angina, Unstable
- How many people
- 900 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2014to May 2016
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on clopidogrel treatment following stent implantation
Who may be able to join
- Patients in whom planned or unplanned stent implantation
- Ages Eligible for Study: 18 Years and older
- Genders Eligible for Study: Both
- Acute coronary syndrome
- ST-segment elevation MI (STEMI)
- non ST-segment elevation MI (STEMI)
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- Stable angina pectoris and or/ documented myocardial ischemia
- Instable angina pectoris and or/ documented myocardial ischemia
- De-novo stenosis of coronary artery with a degree of stenosis between 50% and 99%, that is accessible to PTCA
- Patients on pre-defined group of clopidogrel treatment during and after DES implantation
- Willingness and ability to adhere to the study conditions
- Written informed consent after patient information
Who cannot join
- Known severe arrhythmias that necessitate a long term antiarrhythmic therapy
- Pericarditis
- Intracardiac thrombus
- Bacterial endocarditis
- Patients with contraindication for aortocoronary bypass operation,
- Contraindication to antiplatelet therapy
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- Non-cardiac co-morbid conditions that may result in protocol non-compliance (per site investigator's medical judgment).
- Bleeding diathesis
- Thrombocytopenia (<150 000/mm3)
- Recent (<6 months) gastrointestinal bleeding
- Recent stroke within 6-months
- Concurrent organ damage (creatinine level > 2.0mg/dL or AST and ALT > 3 times upper normal reference values)
- Patients with left main stem stenosis (>50% by visual estimate)
- History of allergy to aspirin
- Inability, to understand sense and purpose of the study
- Patients not willing to keep the conditions of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Non Interventional, Multi-center, Observational Study to Assess the Antiplatelet Treatment Pre and Post-operatively of Stent Implantation
Coronary artery stents, particularly drug-eluting stents (DES), are used in the majority of patients who undergo percutaneous coronary intervention (PCI) to improve symptoms in patients with obstructive coronary artery disease. They function both to prevent abrupt closure of the stented artery soon after the procedure as well as to lower the need for repeat revascularization compared to balloon angioplasty alone . Stent restenosis and stent thrombosis are potential complications of coronary artery stenting; their incidence is highest in the first year after PCI. Stent restenosis, which occurs more frequently with bare metal stents (BMS) than DES, may occasionally present as an acute myocardial infarction (MI). Stent thrombosis is an uncommon but serious complication that often presents as death and is almost always accompanied by MI, usually with ST-segment elevation. Patients are commonly treated with dual antiplatelet therapy (DAPT) for the recommended duration for the particular stent. DAPT (aspirin plus platelet P2Y12 receptor blocker) and significantly lowers the risk of stent thrombosis.
Read the detailed description
New Guidance on Antiplatelet Therapy After Stenting: Clinical Advisory, Kirsten E. Fleischmann, MD, MPH reviewing Grines CL et al. Circulation 2007 Feb 13. An expert panel recommends 12 months of therapy after placement of drug-eluting stents. Aspirin and clopidogrel are commonly prescribed after placement of both bare metal stents and drug-eluting stents. However, recent concerns about stent thrombosis (Journal Watch Jan 4 2007) have led experts from multiple groups, including the American Heart Association and the American College of Cardiology, to issue an advisory on preventing premature discontinuation of dual antiplatelet therapy. Based on a review of the literature, the experts offer observations and recommendations including the following:
- Dual antiplatelet therapy with aspirin and a thienopyridine such as clopidogrel reduces cardiac events after coronary stenting.
- Premature discontinuation of these agents greatly increases the risk for stent thrombosis and associated clinical events such as myocardial infarction and death.
- Patients should receive 12 months of dual antiplatelet therapy after placement of drug-eluting stents.
- Elective surgery associated with a significant risk for bleeding should be postponed until an appropriate course of dual antiplatelet therapy (i.e., 1 month for bare metal stents and 12 months for drug-eluting stents) has been completed.
- Patients' ability to comply with prolonged dual antiplatelet therapy and their need for subsequent invasive procedures should be considered when choosing the type of stent.
- Patients and their other providers should consult with the patient's cardiologist before stopping dual therapy.
Endpoints:
Primary endpoint - Outcome Measures:
- Major Cardiovascular events at 1, 3, 6, 12 months after study enrolment
- All Death,
- Cardiac death,
- Myocardial infarction,
- Stroke,
- Target vessel revascularization
- Bleeding event
- In-stent restenosis (ISR)
- Angiographical Determination of Binary Stenosis Rate (defined as diameter stenosis of at least 50 % in the stent and / or persistent area, 6, 9, 12 months after stent implantation) The angiographical determination of the degree of stenosis, defined as percentage diameter stenosis in the stent and /or persistent area, 6 and 12 months after stent implantation.
- The angiographical determination of the minimal lumen diameter in the stent and / or persistent area, 6 months after stent implantation.
Secondary:
- Description of any reported AE/ SAE per study subgroup.
- Description of any missing doses per study subgroup.
Study Medication:
Category: ADP-P2Y12 interaction blokers
- Clopidogrel (Clovelen®)
- Dosage: As per Clopidogrel (Clovelen®) SmPC
Study Concomitant Medication:
Aspirin. DAT = Dual antiplatelet therapy consists of aspirin add on clopidogrel
- Keywords
- DAT = Dual Antiplatelet Treatment, Major Cardiac Adverse Events
- Medical subject headings
- Angina, Unstable, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel treated patients | Patients pre and post operatively following stent implantation treated with clopidogrel and aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Major Adverse Cardiac Events (MACEs)
All Death,
- Cardiac death,
- Myocardial infarction,
- Stroke,
- Target vessel revascularization (TVR)
- Bleeding event
- In-stent restenosis (ISR)
Measured: 6 months
Secondary outcomes (1)
Number of missed daily doses
Compliance to antiplatelet treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sotirios Patsilinakos, MD, PhD, Study director, Agia Olga Konstantopoulion hospital of AthensNikolaos Kafkas, MD Cardiologist, Principal investigator, KAT General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051361
- Sponsor's protocol ID
- 2013-CLOBES-EL-41
- Acronym
- Anti-Clot
- Status last verified
- May 2016
- First submitted
- 28 Jan 2014
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Non Interventional, Multi-center, Observational Study to Assess the Antiplatelet Treatment Pre and Post-operatively of Stent Implantation
- ClinicalTrials.gov ID
- NCT02051361
- Acronym / sponsor ID
- Anti-Clot / 2013-CLOBES-EL-41
- Keywords
- DAT = Dual Antiplatelet Treatment, Major Cardiac Adverse Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
Coronary artery stents, particularly drug-eluting stents (DES), are used in the majority of patients who undergo percutaneous coronary intervention (PCI) to improve symptoms in patients with obstructive coronary artery disease. They function both to prevent abrupt closure of the stented artery soon after the procedure as well as to lower the need for repeat revascularization compared to balloon angioplasty alone . Stent restenosis and stent thrombosis are potential complications of coronary artery stenting; their incidence is highest in the first year after PCI. Stent restenosis, which occurs more frequently with bare metal stents (BMS) than DES, may occasionally present as an acute myocardial infarction (MI). Stent thrombosis is an uncommon but serious complication that often presents as death and is almost always accompanied by MI, usually with ST-segment elevation. Patients are commonly treated with dual antiplatelet therapy (DAPT) for the recommended duration for the particular stent. DAPT (aspirin plus platelet P2Y12 receptor blocker) and significantly lowers the risk of stent thrombosis.
Detailed description
New Guidance on Antiplatelet Therapy After Stenting: Clinical Advisory, Kirsten E. Fleischmann, MD, MPH reviewing Grines CL et al. Circulation 2007 Feb 13. An expert panel recommends 12 months of therapy after placement of drug-eluting stents. Aspirin and clopidogrel are commonly prescribed after placement of both bare metal stents and drug-eluting stents. However, recent concerns about stent thrombosis (Journal Watch Jan 4 2007) have led experts from multiple groups, including the American Heart Association and the American College of Cardiology, to issue an advisory on preventing premature discontinuation of dual antiplatelet therapy. Based on a review of the literature, the experts offer observations and recommendations including the following:
- Dual antiplatelet therapy with aspirin and a thienopyridine such as clopidogrel reduces cardiac events after coronary stenting.
- Premature discontinuation of these agents greatly increases the risk for stent thrombosis and associated clinical events such as myocardial infarction and death.
- Patients should receive 12 months of dual antiplatelet therapy after placement of drug-eluting stents.
- Elective surgery associated with a significant risk for bleeding should be postponed until an appropriate course of dual antiplatelet therapy (i.e., 1 month for bare metal stents and 12 months for drug-eluting stents) has been completed.
- Patients' ability to comply with prolonged dual antiplatelet therapy and their need for subsequent invasive procedures should be considered when choosing the type of stent.
- Patients and their other providers should consult with the patient's cardiologist before stopping dual therapy.
Endpoints:
Primary endpoint - Outcome Measures:
- Major Cardiovascular events at 1, 3, 6, 12 months after study enrolment
- All Death,
- Cardiac death,
- Myocardial infarction,
- Stroke,
- Target vessel revascularization
- Bleeding event
- In-stent restenosis (ISR)
- Angiographical Determination of Binary Stenosis Rate (defined as diameter stenosis of at least 50 % in the stent and / or persistent area, 6, 9, 12 months after stent implantation) The angiographical determination of the degree of stenosis, defined as percentage diameter stenosis in the stent and /or persistent area, 6 and 12 months after stent implantation.
- The angiographical determination of the minimal lumen diameter in the stent and / or persistent area, 6 months after stent implantation.
Secondary:
- Description of any reported AE/ SAE per study subgroup.
- Description of any missing doses per study subgroup.
Study Medication:
Category: ADP-P2Y12 interaction blokers
- Clopidogrel (Clovelen®)
- Dosage: As per Clopidogrel (Clovelen®) SmPC
Study Concomitant Medication:
Aspirin. DAT = Dual antiplatelet therapy consists of aspirin add on clopidogrel
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel treated patients | – | –Patients pre and post operatively following stent implantation treated with clopidogrel and aspirin |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on clopidogrel treatment following stent implantation
Key inclusion criteria (12 listed)
- Patients in whom planned or unplanned stent implantation
- Ages Eligible for Study: 18 Years and older
- Genders Eligible for Study: Both
- Acute coronary syndrome
- ST-segment elevation MI (STEMI)
Key exclusion criteria (16 listed)
- Known severe arrhythmias that necessitate a long term antiarrhythmic therapy
- Pericarditis
- Intracardiac thrombus
- Bacterial endocarditis
- Patients with contraindication for aortocoronary bypass operation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Major Adverse Cardiac Events (MACEs)
Time frame: 6 months
All Death, * Cardiac death, * Myocardial infarction, * Stroke, * Target vessel revascularization (TVR) * Bleeding event * In-stent restenosis (ISR)
1 secondary outcome
Number of missed daily doses
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Sotirios Patsilinakos, MD, PhD study director
Agia Olga Konstantopoulion hospital of Athens
Nikolaos Kafkas, MD Cardiologist principal investigator
KAT General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Coronary Syndrome, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
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 12 inclusion and 16 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 18 May 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 Greece. 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.
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?
Number of Major Adverse Cardiac Events (MACEs) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2016.