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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets

Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets

The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.

A study comparing cardiovascular effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease

A randomized, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)

NCT ID

Therapeutic Area

Research Site

However, the actual duration of the study will be based on accrual of the predetermined number of events (1364) for the primary endpoint, and therefore the study may be shorter or longer than 40 months The anticipated median duration is 32 months.

Ethnicity, Customized

Gender, Male/Female

Race, Customized

Age Continuous

Age, Customized

Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date)

The population was the full analysis set, which included all randomized patients.

Composite of Cardiovascular (CV) death/MI/ischemic stroke

Participants with CV death, MI, ischemic stroke or acute limb ischemia (ALI). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

The population was the full analysis set, which included all randomized patients

Composite of CV death, MI, ischemic stroke, and ALI

Participants with CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

CV death

Participants with MI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Participants with all-cause death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

All-cause mortality

Participants with CV death, MI or all-cause stroke. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

Composite of CV death, MI, and all-cause stroke (ischemic or hemorrhagic)

Participants with ALI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Participants with lower extremity revascularization (LER). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Lower extremity revascularization

Participants with any revascularization. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Any revascularisation (coronary, peripheral [limb, mesenteric, renal, carotid and other])

Participants with CV death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)

Net clinical benefit (composite of CV death/MI/ischemic stroke/fatal bleeding/intracranial bleeding)

Participants with all-cause death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

Net clinical benefit (composite of all-cause mortality/MI/ischemic stroke/fatal bleeding/intracranial bleeding)

Participants with all-cause death, MI, ischemic stroke, ALI, major amputation, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

Net clinical benefit (composite of all-cause mortality/MI/ischemic stroke/ALI/major amputation/fatal
bleeding/intracranial bleeding)

Participants with all-cause death, MI, ischemic stroke, ALI, major amputation or Thrombolysis in Myocardial Infarction (TIMI) major bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)

Net clinical benefit (composite of all-cause mortality/MI/ischemic stroke/ALI/major amputation/TIMI major bleeding)

Participants with non-CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, CV death)

Non-CV death

Stage I
- 
End of treatment

Stage IIa
- 
End of treatment

Stage IIb
- 
End of treatment

Stage III
- 
End of treatment

Stage IV
- 
End of treatment

Missing
-
End of treatment

Progression of the clinical/symptomatic status of the limb by changes in Fontaine stage.

Stage I – Asymptomatic
Stage IIa – Intermittent claudication after more than 200 meters of pain free walking
Stage IIb – Intermittent claudication after less than 200 meters of walking
Stage III – Rest pain
Stage IV – Ischemic ulcers or gangrene

Changes in Fontaine stage

Category 0
- 
End of treatment

Category 1/2
- 
End of treatment

Category 3
- 
End of treatment

Category 4
- 
End of treatment

Category 5
- 
End of treatment

Category 6
- 
End of treatment

Progression of the clinical/symptomatic status of the limb by changes in Rutherford classification.

Category 0 – Asymptomatic
Category 1 – Mild claudication
Category 2 – Moderate claudication – The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Category 3 – Severe claudication
Category 4 – Rest pain
Category 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot
Category 6 – Severe ischemic ulcers or frank gangrene

Changes in Rutherford classification

ABI - 6 months
N = 6184(Tica), 6319(Clopi)

ABI - End of treatment
N = 4951(Tica), 5073(Clopi)

TBI - 6 months
N = 55(Tica), 48(Clopi)

TBI - End of treatment
N = 36(Tica), 21(Clopi)

Change in ankle brachial index (ABI) / toe brachial index (TBI).

Ankle brachial index (ABI) is the ratio of blood pressures from the ankle and arm and is used for diagnosing peripheral arterial occlusive disease (PAOD):

Normal: 1 to 1.29
Borderline: 0.91 to 0.99
Mild PAOD: 0.71 to 0.90
Medium severe PAOD: 0.41 to 0.7
Severe PAOD: <0.4

Toe brachial index (TBI) is the ratio between the toe pressure and the higher brachial pressure, used for diagnosing PAOD when the ABI cannot be used:

Normal: >0.7
Mild: 0.5-0.7
Moderate: 0.35-0.5
Moderate-Severe: <0.35 and toe pressure 40 mmHg
Severe: <0.35 and toe pressure < 30 mmHg

Change in ABI/TBI from baseline

Participants with any amputation caused by peripheral arterial disease (PAD). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Any amputation caused by PAD

Participants with major amputation caused by PAD. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

Major amputation caused by PAD

Participants with hospitalization associated with CV death, hospitalization due to MI, ischemic stroke, lower extremity revascularization, major amputation due to PAD, transient ischemic attack (TIA), coronary revascularization or unstable angina. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)

CV-related hospitalization

Participants with TIMI major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)

The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available

TIMI major bleeding events

Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)

TIMI major or minor bleeding events

Participants with PLATO major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)

PLATO major bleeding events

Participants with a permanent discontinuation of study drug due to any bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)

The population was the saftey analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available

Premature permanent discontinuation of study drug due to any bleeding event

Overall Study

Screened patients randomised to study drug: 85.5%; n=13885
Patients who were not randomised: 14.5%; n=2352
Patients with inclusion criteria for symptomatic lower extremity PAD failed: n=489
Patients with poor metabolizer status for CYP2C19: n=616
Patients with other reason: n=1374

Arms	Assigned Interventions
Experimental: Ticagrelor Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets	Drug: Ticagrelor Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets Other Name: Brilinta/Brilique
Active Comparator: Clopidogrel Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets	Drug: Clopidogrel Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets Other Name: Plavix

A study comparing cardiovascular effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease - EUCLID

Official Title

Medical condition

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Healthy volunteers

Study drug

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Actual Enrollment

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Redacted Protocol

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