Angina, StableMECCANCT03759067
Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients
A study testing clopidogrel 75mg, Clopidogrel 300 mg and clopidogrel 600mg in people with Angina, Stable, run by Korea University Anam Hospital.
Trial summary
The study included 511 patients who underwent PCI because of angina during 2010-2011 at three Korean hospitals. Clopidogrel-naïve patients received either a loading dose (LD; 600 mg at 2-24 h before the procedure) or routine maintenance therapy (75 mg/day for ≥5 days) plus either a 300-mg reload (RL) or only the… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Angina, Stable
- What is being tested?
- clopidogrel 75mg, Clopidogrel 300 mg and clopidogrel 600mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- No sites listed yet
- Study dates
- 18 Oct 2010to 31 Jul 2013
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and, stable angina pectoris and, at least 1 ischemic evidence below
- Treadmil test positive
- ST-T change in resting ECG or 24-hour ECG
- Regional wall motion abnormality in Echocardiography or cardiac MRI
- Myocardial ischemia at MIBI scan
- moderate to severe stenosis at coronary CT angiography
- chest pain or dyspnea
Who cannot join
- AST or ALT > 3 times upper normal limits
- Serum creatinine > 2.0 mg/dL
- chronic malaborption status (disorder or operation)
- planned surgery within 1 year
- pregnancy or breast-feeding patients
- life expectancy < 1 year
About this study
Official title: Prospective Partially Randomized Comparison of Clopidogrel Loading Versus Maintenance Dosing to Prevent Periprocedural Myocardial Infarction After Stenting for a Stable Angina Pectoris
The study included 511 patients who underwent PCI because of angina during 2010-2011 at three Korean hospitals. Clopidogrel-naïve patients received either a loading dose (LD; 600 mg at 2-24 h before the procedure) or routine maintenance therapy (75 mg/day for ≥5 days) plus either a 300-mg reload (RL) or only the maintenance dose (MD).
Read the detailed description
Elevation of myocardial infarction markers after coronary stenting reflects periprocedural myonecrosis or periprocedural myocardial infarction (PMI), which is associated with an increase in cardiac events and mortality. Thus, we aimed to evaluate various clopidogrel pre-treatment methods for preventing PMI among patients undergoing conventional CAG for stable angina pectoris. The Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina patients (MECCA) study was a prospective, partially randomized, multi-center clinical trial. Between October 2010 and July 2011, 511 patients underwent PCI for angina pectoris at the Korean University Anam Hospital, the Eulji Hospital, and the Hanil General Hospital. Clopidogrel-naïve patients were enrolled to receive a loading dose (the LD group; clopidogrel at 600 mg, usually 2-24 h before the procedure) or routine therapy using daily clopidogrel doses (75 mg/day for ≥5 days). Patients receiving daily doses were randomized to receive either an additional 300-mg reload (the RL group) or no additional loading (the maintenance dose [MD] group). The 600-mg or 75-mg treatment regimens were selected at the physician's discretion. The primary outcome was creatinine kinase myocardial band (CK-MB) levels at several time points. The CK-MB levels were measured at baseline, 8 h, and 24 h, while troponin-I levels were measured at 8 h after the PCI.
- Conditions
- Angina, Stable
- Being tested
- clopidogrel 75mg, Clopidogrel 300 mg, clopidogrel 600mg
- Keywords
- clopidogrel loading, maintenance dose, periprocedural MI
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrel 75mgDrug
Also called MD
clopidogrel once daily 75mg
Clopidogrel 300 mgDrug
Also called RL
clopidogrel 300mg reloading
clopidogrel 600mgDrug
Also called LD
clopidogrel 600mg loading
| Study group | Role | What they receive |
|---|---|---|
| LD group | Active comparator | clopidogrel 600 mg once loading, usually 2-24 h before the procedure Receives: Drug: clopidogrel 600mg |
| MD group | Experimental | After randomization, the routine therapy using daily clopidogrel 75mg Receives: Drug: clopidogrel 75mg |
| RL group | Active comparator | After randomization, additional clopidogrel 300 mg reloading for patients who were taking a maintenance dose. Receives: Drug: clopidogrel 75mg; Drug: Clopidogrel 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
8hour mean CK-MB
mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI
Measured: 8hour after PCI
24hour mean CK-MB
mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI
Measured: 24hour after PCI
Secondary outcomes (4)
8hour mean troponin-I
mean troponin-I is checked 8hour after PCI
Measured: 8hour after PCI
Prevalence of periprocedural myocardial infarction (PMI)
Patients were considered to have PMI when their CK-MB level was elevated to >3 times the upper limit of normal, which was defined as 4.94 ng/mL.
Measured: 8hour or 24hour after PCI
All cause death
All death is evaluated using chart reviews and telephone calls.
Measured: 9 months after PCI
Coronary revascularization
Coronary revascularization is evaluated using chart reviews and telephone. calls.
Measured: 9 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start18 Oct 2010
- Primary completion31 Jan 2012
- Study completion31 Jul 2013
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 Angina, StableStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-sun Lim, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759067
- Sponsor's protocol ID
- KUMC_MECCA
- Acronym
- MECCA
- Status last verified
- Nov 2018
- First submitted
- 28 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. 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. No abstract available.
PubMed 21670242
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Partially Randomized Comparison of Clopidogrel Loading Versus Maintenance Dosing to Prevent Periprocedural Myocardial Infarction After Stenting for a Stable Angina Pectoris
- ClinicalTrials.gov ID
- NCT03759067
- Acronym / sponsor ID
- MECCA / KUMC_MECCA
- Conditions
- Angina, Stable
- Keywords
- clopidogrel loading, maintenance dose, periprocedural MI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 18 Oct 2010 (actual)
- Primary completion
- 31 Jan 2012 (actual)
- Study completion
- 31 Jul 2013 (actual)
- First posted
- 29 Nov 2018 (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.
The study included 511 patients who underwent PCI because of angina during 2010-2011 at three Korean hospitals. Clopidogrel-naïve patients received either a loading dose (LD; 600 mg at 2-24 h before the procedure) or routine maintenance therapy (75 mg/day for ≥5 days) plus either a 300-mg reload (RL) or only the maintenance dose (MD).
Detailed description
Elevation of myocardial infarction markers after coronary stenting reflects periprocedural myonecrosis or periprocedural myocardial infarction (PMI), which is associated with an increase in cardiac events and mortality. Thus, we aimed to evaluate various clopidogrel pre-treatment methods for preventing PMI among patients undergoing conventional CAG for stable angina pectoris. The Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina patients (MECCA) study was a prospective, partially randomized, multi-center clinical trial. Between October 2010 and July 2011, 511 patients underwent PCI for angina pectoris at the Korean University Anam Hospital, the Eulji Hospital, and the Hanil General Hospital. Clopidogrel-naïve patients were enrolled to receive a loading dose (the LD group; clopidogrel at 600 mg, usually 2-24 h before the procedure) or routine therapy using daily clopidogrel doses (75 mg/day for ≥5 days). Patients receiving daily doses were randomized to receive either an additional 300-mg reload (the RL group) or no additional loading (the maintenance dose [MD] group). The 600-mg or 75-mg treatment regimens were selected at the physician's discretion. The primary outcome was creatinine kinase myocardial band (CK-MB) levels at several time points. The CK-MB levels were measured at baseline, 8 h, and 24 h, while troponin-I levels were measured at 8 h after the PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LD group | Active comparator | Drug: clopidogrel 600mgclopidogrel 600 mg once loading, usually 2-24 h before the procedure |
| MD group | Experimental | Drug: clopidogrel 75mgAfter randomization, the routine therapy using daily clopidogrel 75mg |
| RL group | Active comparator | Drug: clopidogrel 75mg, Drug: Clopidogrel 300 mgAfter randomization, additional clopidogrel 300 mg reloading for patients who were taking a maintenance dose. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent and, stable angina pectoris and, at least 1 ischemic evidence below
Key exclusion criteria (6 listed)
- AST or ALT > 3 times upper normal limits
- Serum creatinine > 2.0 mg/dL
- chronic malaborption status (disorder or operation)
- planned surgery within 1 year
- pregnancy or breast-feeding patients
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 |
|---|---|---|
| clopidogrel 75mgAlso: MDclopidogrel once daily 75mg | Drug | MD group, RL group |
| Clopidogrel 300 mgAlso: RLclopidogrel 300mg reloading | Drug | RL group |
| clopidogrel 600mgAlso: LDclopidogrel 600mg loading | Drug | LD group |
Primary outcome
8hour mean CK-MB
Time frame: 8hour after PCI
mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI
24hour mean CK-MB
Time frame: 24hour after PCI
mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI
4 secondary outcomes
8hour mean troponin-I
Time frame: 8hour after PCI
Prevalence of periprocedural myocardial infarction (PMI)
Time frame: 8hour or 24hour after PCI
All cause death
Time frame: 9 months after PCI
Coronary revascularization
Time frame: 9 months after PCI
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 29 Nov 2018.
- Background: PubMed 21670242Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. 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. No abstract available.
- GUSTO bleedingLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing clopidogrel 75mg, Clopidogrel 300 mg and clopidogrel 600mg in people with Angina, Stable, run by Korea University Anam Hospital.
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 7 inclusion and 6 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 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
8hour mean CK-MB (time frame: 8hour after PCI). The study lists 2 primary outcomes in all. 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 NCT03759067, 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 29 Nov 2018.